Medtronic AB2214C140CT Instructions for Use

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Talent™ Abdominal Stent Graft System

Instructions for Use

IMPORTANT!

• Do not attempt to use the Talent Abdominal Stent Graft with the CoilTrac Delivery System before completely reading and understanding

the information contained in this booklet.

• Carefully inspect all product packaging for damage or defects prior to use. Do not use this product if any sign of damage or breach of the sterile barrier is observed.

• These devices are supplied STERILE for single use only. After use, dispose of the delivery catheters in accordance with hospital, administrative, and/or government policy. Do not resterilize.

• Caution: Federal (U.S.) Law restricts this device to sale by or on the order of a physician

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Table of Contents

Talent™ Abdominal Stent Graft System

Instructions for Use

1.0 DEVICE DESCRIPTION...................................................................................................................... 5

1.1 DEVICE COMPONENTS .......................................................................................................................... 7

1.2 DELIVERY SYSTEM ............................................................................................................................... 9

2.0 INDICATIONS..................................................................................................................................... 11

3.0 CONTRAINDICATIONS.................................................................................................................... 11

4.0 WARNINGS AND PRECAUTIONS .................................................................................................. 11

4.1 GENERAL ............................................................................................................................................ 11

4.2 PATIENT SELECTION, TREATMENT, AND FOLLOW-UP......................................................................... 11

4.3 IMPLANT PROCEDURE......................................................................................................................... 12

4.4 MAGNETIC RESONANCE IMAGING (MRI) SAFETY SECTION ............................................................... 13

5.0 ADVERSE EVENTS ............................................................................................................................ 13

5.1 OBSERVED ADVERSE EVENTS ............................................................................................................ 13

5.2 POTENTIAL ADVERSE EVENTS ............................................................................................................ 13

5.3 DEVICE-RELATED ADVERSE EVENTS REPORTING .............................................................................. 13

6.0 SUMMARY OF CLINICAL STUDY ................................................................................................. 14

6.1 STENT GRAFT ANALYSIS .................................................................................................................... 14

6.2 DELIVERY SYSTEM ANALYSIS ............................................................................................................ 14

6.3 PATIENT ACCOUNTABILITY AND FOLLOW-UP .................................................................................... 15

6.4 DEMOGRAPHIC AND BASELINE MEDICAL HISTORY DATA .................................................................. 17

6.5 BASELINE ANEURYSM DATA .............................................................................................................. 19

6.6 DEVICES IMPLANTED .......................................................................................................................... 21

6.7 STUDY RESULTS ................................................................................................................................. 22

6.8 SAFETY............................................................................................................................................... 22

6.9 EFFECTIVENESS .................................................................................................................................. 29

6.10 ACUTE PROCEDURAL DATA.............................................................................................................. 34

6.11 COILTRAC DELIVERY SYSTEM PERFORMANCE DATA....................................................................... 35

7.0 PATIENT SELECTION ...................................................................................................................... 36

7.1 INDIVIDUALIZATION OF TREATMENT .................................................................................................. 36

8.0 PATIENT COUNSELING INFORMATION .................................................................................... 36

9.0 HOW SUPPLIED ................................................................................................................................. 36

9.1 CONTENTS .......................................................................................................................................... 36

9.2 STERILITY AND STORAGE ................................................................................................................... 37

10.0 CLINICAL USE INFORMATION...................................................................................................37

10.1 RECOMMENDED SKILLS AND TRAINING............................................................................................ 37

10.2 MATERIAL RECOMMENDED FOR DEVICE IMPLANTATION ................................................................. 37

10.3 PRE-TREATMENT PLANNING............................................................................................................. 37

11.0 DIRECTIONS FOR USE – STENT GRAFT SYSTEM ................................................................. 39

11.1 PICTORIAL REFERENCES ................................................................................................................... 39

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11.2 VASCULAR ACCESS AND ARTERIOTOMY .......................................................................................... 39

11.3 IMPLANTATION OF THE BIFURCATED STENT GRAFT ......................................................................... 39

11.4 IMPLANTATION OF THE CONTRALATERAL LIMB ............................................................................... 45

11.5 AORTIC AND ILIAC EXTENSIONS....................................................................................................... 47

12.0 IMAGING GUIDELINES AND POST-OPERATIVE FOLLOW-UP.......................................... 49

12.1 GENERAL .......................................................................................................................................... 49

12.2 CONTRAST AND NON-CONTRAST CT RECOMMENDATIONS .............................................................. 49

12.3 ABDOMINAL RADIOGRAPHS ............................................................................................................. 50

12.4 ULTRASOUND ................................................................................................................................... 50

12.5 MRI SAFETY AND COMPATIBILITY ................................................................................................... 50

12.6 ADDITIONAL SURVEILLANCE AND TREATMENT................................................................................ 51

13.0 DEVICE-RELATED ADVERSE EVENTS REPORTING ............................................................ 51

14.0 PATIENT MATERIALS AND TRACKING INFORMATION .................................................... 51

15.0 CONFIGURATIONS AVAILABLE ................................................................................................ 52

16.0 EXPLANATION OF SYMBOLS...................................................................................................... 54

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List of Tables

Table 1: Stent Graft Materials ........................................................................................................................ 5

Table 2: Patient and Imaging Accountability – Test Group1........................................................................ 15

Table 3: Patient Accountability – SVS Control............................................................................................ 16

Table 4: Patient Demographics, Test Group vs. SVS Control...................................................................... 17

Table 5: Baseline Medical History, Test Group vs. SVS Control ................................................................ 18

Table 6: Baseline SVS Classification, Test Group Only.............................................................................. 19

Table 7: Baseline Maximum Aneurysm Diameters, Test Group vs. SVS Control (Site Reported) ............. 19

Table 8: Distribution of Baseline Maximum Aneurysm Diameters, Test Group vs. SVS Control (Site

Reported)...................................................................................................................................................... 19

Table 9: Baseline Aneurysm Characteristics, Test Group............................................................................ 20

Table 10: Total Number of Talent Abdominal Stent Grafts Implanted at Initial Procedure......................... 21

Table 11: Primary Safety Endpoint: Freedom from MAEs within 30 Days, Test Group vs. SVS Control.. 22

Table 12: Primary Safety Endpoint: MAE Components within 30 Days, Test Group vs. SVS Control ...... 22

Table 13: Freedom from MAEs within 365 Days, Test Group vs. SVS Control ........................................ 23

Table 14: MAE Components within 365 Days, Test Group vs. SVS Control............................................. 23

Table 15: Details of Kaplan-Meier Estimates of Freedom from MAEs (0 to 365 Days), Test Group vs.

SVS Control ................................................................................................................................................. 24

Table 16: Freedom from All-Cause Mortality within 30 Days, Test Group vs. SVS Control..................... 25

Table 17: Freedom from Aneurysm-Related Mortality within 365 Days, Test Group vs. SVS Control..... 25

Table 18: Details of Kaplan-Meier Estimates of Freedom from Aneurysm-Related Mortality within 365

Days, Test Group vs. SVS Control.............................................................................................................. 26

Table 19: Freedom from All-Cause Mortality within 365 Days, Test Group vs. SVS Control.................... 27

Table 20: Details of Kaplan-Meier Estimates of Freedom from All-Cause Mortality within 365 Days,

Test Group vs. SVS Control......................................................................................................................... 28

Table 21: Primary Effectiveness Endpoint: Successful Aneurysm Treatment, Test Group ......................... 29

Table 22: Primary Effectiveness Endpoint: Successful Aneurysm Treatment, Test Group ......................... 29

Table 23: Migration-Free at 12 Months, Test Group (Core Lab) ................................................................. 30

Table 24: Stent Graft Patency at 12 Months, Test Group (Core Lab) .......................................................... 30

Table 25: Freedom from Secondary Endovascular Procedures within 365 Days, Test Group..................... 30

Table 26: Loss of Stent Graft Integrity at 12 Months, Test Group (Core Lab) ............................................ 31

Table 27: Type I/III Endoleak-Free at 12 Months, Test Group (Core Lab) ................................................. 31

Table 28: Summary of All Endoleaks at 1 Month and 12 Months, Test Group (Core Lab)......................... 32

Table 29: Aneurysm Rupture within 365 Days, Test Group ........................................................................ 33

Table 30: Aneurysm Change from 1 Month to 12 Months, Test Group (Core Lab and Site-Reported) ..... 33

Table 31: Acute Procedural Data, Test Group and SVS Control ................................................................. 34

Table 32: CoilTrac Delivery System: Delivery and Deployment Success .................................................. 35

Table 33: CoilTrac Delivery System: Patients with Clinically Relevant Adverse Events

[Within 30 Days] .......................................................................................................................................... 35

Table 34: Talent Abdominal Stent Graft System Oversizing Guidelines..................................................... 38

Table 35: Guideline for balloon diameter to volume.................................................................................... 44

Table 36: Recommended Imaging Schedule for Endovascular Graft Patients ............................................. 49

Table 37: Accepted Imaging Protocols......................................................................................................... 50

Table 38: Bifurcated Stent Grafts with the CoilTrac Delivery System ........................................................ 52

Table 39: Contralateral Limbs with the CoilTrac Delivery System ............................................................. 52

Table 40: Iliac Extension Cuffs with CoilTrac Delivery System ................................................................. 53

Table 41: Aortic Extension Cuffs with CoilTrac Delivery System .............................................................. 53

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List of Figures

Figure 1: Overview of Talent Abdominal Stent Graft Components............................................................... 6

Figure 2: Talent Abdominal Bifurcated Stent Graft....................................................................................... 7

Figure 3: Talent Abdominal Contralateral Iliac Limb.................................................................................... 8

Figure 4: Talent Abdominal Iliac (Left) and Aortic (Right) Extension Cuffs ................................................ 8

Figure 5: CoilTrac Delivery System............................................................................................................. 10

Figure 6: Kaplan-Meier Estimates of Freedom from MAEs (0 to 365 Days), Test Group vs. SVS

Control.......................................................................................................................................................... 24

Figure 7: Kaplan-Meier Estimates of Freedom from Aneurysm-Related Mortality within 365 Days, Test

Group vs. SVS Control................................................................................................................................. 26

Figure 8: Kaplan-Meier Estimates of Freedom from All-Cause Mortality within 365 Days, Test Group

vs. SVS Control............................................................................................................................................ 28

Figure 9: Position the System....................................................................................................................... 40

Figure 10: Deploy the Proximal End............................................................................................................ 42

Figure 11: Deploy the Distal End ................................................................................................................. 43

Figure 12: Modeling the Stent Graft with the Balloon ................................................................................. 44

Figure 13: Proper Docking of Contralateral Limb to Contralateral Leg....................................................... 46

Figure 14: Talent Stent Graft System with the Modeling Balloon ............................................................... 47

Figure 15: Orienting Iliac Extension Cuff .................................................................................................... 48

Figure 16: Orienting the Aortic Extension Cuff........................................................................................... 48

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1.0 DEVICE DESCRIPTION

The Talent™ Abdominal Stent Graft System is comprised of two main components: an implantable stent graft and a disposable delivery system. The pre-loaded stent graft is advanced to the aneurysm location over a guidewire and, upon retraction of an introducer sheath (graft cover), expands to the indicated diameter. During deployment and expansion, the stent graft is intended to form proximal and distal seal zones surrounding the aneurysm location.

The Talent Abdominal Stent Graft System is modular and consists of four stent graft component configurations:

• Bifurcated (aorto-iliac)

• Contralateral iliac limb

• Iliac extension cuff

• Aortic extension cuff

Each component is introduced separately into the patient’s vascular system. Each stent graft component is comprised of nitinol metal springs attached to polyester fabric graft material. For all configurations the proximal and distal springs are attached to connecting bars to provide additional columnar strength to the stent graft. The springs are sewn to the polyester fabric graft using polyester suture material. Radiopaque markers, made out of platinum-iridium in the shape of a figure eight (aka, Figur8), are sewn onto the stent graft to aid in visualization of the stent graft under fluoroscopy and to facilitate accurate placement of the device. See Table 1 for a listing of stent graft materials and Figure 1 for an overview of stent graft components.

The stent graft is designed to be placed in the native vessel such that the unconstrained stent graft diameter is larger than the diameter of the native vessel into which it is to be placed. This “oversizing” helps to exclude the aneurysm from aortic blood flow and ensure that the stent graft is held in place. The amount of oversizing required is dependent on the diameter of the native vessel. See Table 34 for oversizing guidelines and Section 15.0 available device configurations.

Table 1: Stent Graft Materials

Stent Graft Component Material

Springs Nitinol wire Connecting Bar Nitinol wire Mini-Support Spring (FreeFlo only) Nitinol wire Stent Fabric Woven polyester Sutures Braided polyester suture Figur8 Radiopaque Markers Platinum-Iridium wire

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Figure 1: Overview of Talent Abdominal Stent Graft Components

AORTIC

EXTENSION CUFF

Connecting Bar

Mini-support Spring

BIFURCATED

STENT GRAFT

ILIAC

EXTENSION CUFF

Connecting Bar

Mini-support Spring

CONTRALATERAL

LIMB

Connecting Bar

= Figur8 Radiopaque Marker

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1.1 Device Components

Each of the four stent graft configurations is described in the following section.

1.1.1 Bifurcated Stent Graft

The bifurcated component (Figure 2) is the primary component which is inserted into the patient’s aorta. The proximal end of all bifurcated stent grafts has a bare spring that is not covered with graft material to allow for supra-renal fixation. Bifurcated stent grafts with a proximal diameter greater than 22mm have a mini-support spring to aid in sealing. The proximal end configuration in which a bare spring and minisupport spring are present is called the ‘FreeFlo’ configuration. The proximal end configuration in which a bare spring is present without a mini-support spring is called a ‘Bare Spring’ configuration.

The stent graft bifurcates into two smaller iliac diameters; one of which is placed into the ipsilateral iliac artery, and the other of which is available to receive the contralateral iliac component. The distal end of the short contralateral leg is 14mm in diameter for all sizes of stent grafts so that it can receive all available contralateral limb stent graft configurations. In contrast the distal end of the ipsilateral leg is available in 12, 14, 16, 18 and 20mm diameters. The distal iliac ends of the stent graft have Closed Web configurations.

140-170mm

Figure 2: Talent Abdominal Bifurcated Stent Graft

22-36mm

50mm

FreeFlo Configuration Shown [22mm size has Bare Spring configuration without mini-support spring (not shown in

14mm

Closed Web

Configuration

12-20mm

the figure)]

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1.1.2 Contralateral iliac limb

The contralateral iliac limb component (Figure 3) is implanted after the bifurcated component to provide a conduit for blood flow into the contralateral iliac artery. The contralateral iliac limb is introduced though the patient’s contralateral iliac artery and mated to the short contralateral stub leg on the bifurcated stent graft.

The proximal end of the contralateral iliac limb has an Open Web configuration in which the outline of the most proximal spring is covered. The proximal diameter is 14mm for all limb sizes, so that all limbs can dock with all available bifurcated stent graft configurations. The distal end of the limb has a Closed Web configuration.

1.1.3 Aortic and Iliac Extension Cuffs

1.1.3.1 The aortic and iliac extension cuff components (Figure 4) are used to extend the lengths of implanted devices as needed based on the patient’s anatomy.

Figure 4: Talent Abdominal Iliac (Left) and Aortic (Right) Extension Cuffs

Open Web

Configuration

Closed Web

Configuration

Figure 3: Talent Abdominal Contralateral Iliac Limb

Open Web Configuration

Closed Web Configuration

10-22mm

8-24mm

14mm

75-105mm

8-24mm

FreeFlo Configuration Shown

[22mm size has Bare Spring

configuration without mini-support

spring (not shown in the figure)]

74 - 140mm

Open Web Configuration

22-36mm

26-30mm

22-36mm

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1.2 Delivery System

The CoilTrac Delivery System is a single use, disposable system used to deliver all stent graft configurations.

The CoilTrac Delivery System is shown in Figure 5. It is a flexible catheter constructed of three concentric, single lumen, polymer shafts (an outer introducer sheath [graft cover], a pushrod, and a guidewire lumen). A metallic coil with cup plunger is attached to the distal end of the pushrod to maintain stent graft position during deployment. A polymeric, atraumatic tapered tip is attached to the guidewire lumen at the distal end of the delivery system to facilitate tracking through tortuous and calcified vessels. The radiopaque, tapered tip and marker on the distal end of the introducer sheath (graft cover) aid in fluoroscopic visualization. A compliant balloon is located on the distal end of the delivery system to aid in stent graft modeling if necessary. Various valves contained within the delivery system maintain hemostasis and prevent blood loss and leaking during the procedure.

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Figure 5: CoilTrac Delivery System

1 Guidewire Exit Port 11 Stopcock 2 Tuohy Borst 12 Inflation Port 3 Luer Handle 13 Y-Connector 4 Sheath Hub 14 Guidewire Lumen

Introducer Sheath

(Graft Cover) 6 Cup Plunger 16 Hemostasis Valve 7 Pushrod Coil Spring 17 Stopcock 8 Radiopaque “Bullet” 18 Sideport Extension 9 Distal Point 19 Radiopaque Marker

10 Tapered Tip 20 Balloon

15 Pushrod

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2.0 INDICATIONS

The Talent Abdominal Stent Graft is indicated for the endovascular treatment of abdominal aortic aneurysms with or without iliac involvement having:

• Iliac/femoral access vessel morphology that is compatible with vascular access techniques, devices, and/or accessories;

• A proximal aortic neck length of ≥ 10mm;

• Proximal aortic neck angulation ≤ 60°;

• Distal iliac artery fixation length of ≥ 15mm;

• An aortic neck diameter of 18–32mm and iliac artery diameters of 8–22mm; and

• Vessel morphology suitable for endovascular repair.

3.0 CONTRAINDICATIONS

The Talent Abdominal Stent Graft is contraindicated in:

• Patients who have a condition that threatens to infect the graft.

• Patients with sensitivities or allergies to the device materials (see Table 1).

4.0 WARNINGS AND PRECAUTIONS

4.1 General

• Read all instructions carefully. Failure to properly follow the instructions, warnings and precautions may lead to serious consequences or injury to the patient

• The Talent Abdominal Stent Graft System should only be used by physicians and teams trained in vascular interventional techniques, including training in the use of the device. Specific training expectations are described in Section 10.1.

• Always have a vascular surgery team available during implantation or reintervention procedures in the event that conversion to open surgical repair is necessary

4.2 Patient Selection, Treatment, and Follow-Up

• The Talent Abdominal Stent Graft System is not recommended in patients unable to undergo or who will not be compliant with the necessary preoperative and postoperative imaging and implantation studies as described in Section 12.0.

• The Talent Abdominal Stent Graft System is not recommended in patients who cannot tolerate contrast agents necessary for intra-operative and post-operative follow-up imaging.

• The Talent Abdominal Stent Graft System is not recommended in patients exceeding weight and/or size limits which compromise or prevent the necessary imaging requirements

• Prior to the procedure, pre-operative planning for access and placement should be performed. See Section 10.3. Key anatomic elements that may affect successful exclusion of the aneurysm include severe proximal neck angulation (> 60 °); short proximal aortic neck (< 10mm); and thrombus and/or calcium at the arterial implantation sites, specifically the proximal aortic neck and distal iliac artery interface. Irregular calcification and/or plaque may compromise the fixation and sealing of the implantation sites. Necks exhibiting these key anatomic elements may be more conducive to graft migration.

• Iliac conduits may be used to ensure the safe insertion of the delivery system if the patient’s access vessels (as determined by treating physician) preclude safe insertion of the delivery system.

• Inappropriate patient selection may contribute to poor device performance.

• The safety and effectiveness of the Talent Abdominal Stent Graft System has not been evaluated in

patients who:

 Are less than 18 years of age  Are pregnant or lactating  Have a dominant patent inferior mesenteric artery and an occluded or stenotic celiac and/or superior

mesenteric artery

 Have aneurysmal involvement or occlusion (surgically performed or naturally occurring) of the

bilateral internal iliac arteries

 Have vessels and/or aneurysm dimensions that cannot accommodate the Talent Abdominal Stent

Graft as per the indications in Section 2.0.

 Have no distal vascular bed (one vessel lower extremity run-off required)  Have contraindications for use of contrast medium or anticoagulation drugs  Have an uncorrectable coagulopathy  Have a mycotic aneurysm  Have circumferential mural thrombus in the proximal aortic neck  Have had a recent (within 3 months) myocardial infarction (MI), cerebral vascular accident (CVA), or

major surgical intervention

 Have traumatic aortic injury  Have leaking, pending rupture or ruptured aneurysms

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 Have pseudoaneurysms resulting from previous graft placement  Require a revision to previously placed endovascular stent grafts..  Have genetic connective tissue disease (e.g., Marfan's or Ehlers-Danlos' Syndromes)  Have concomitant thoracic aortic or thoracoabdominal aneurysms  Are patients with active systemic infections

• The long-term performance of endovascular grafts has not yet been established. All patients should be advised that endovascular treatment requires lifelong, regular follow-up to assess their health and the performance of their endovascular graft. Patients with specific clinical findings (e.g., endoleaks, enlarging aneurysms or changes in the structure or position of the endovascular graft) should receive enhanced follow-up. Specific follow-up guidelines are described in Section 12.0.

• After endovascular graft placement, patients should be regularly monitored for perigraft flow, aneurysm growth or changes in the structure or position of the endovascular graft. At a minimum, annual imaging is required, including: 1) abdominal radiographs to examine device integrity (stent fracture, separation between bifurcated device and proximal cuffs or limb extensions, if applicable), and 2) contrast and noncontrast CT to examine aneurysm changes, perigraft flow, patency, tortuosity and progressive disease. If renal complications or other factors preclude the use of image contrast media, abdominal radiographs and duplex ultrasound may provide similar information.

• Patients experiencing reduced blood flow through the graft limb and/or leaks may be required to undergo secondary interventions or surgical procedures.

• Intervention or conversion to standard open surgical repair following initial endovascular repair should be considered for patients experiencing enlarging aneurysms and/or endoleak. An increase in aneurysm size and/or persistent endoleak may lead to aneurysm rupture.

4.3 Implant Procedure

• Exercise care in handling and delivery technique to aid in the prevention of vessel rupture.

• Studies indicate that the danger of micro-embolization increases with increased duration of the procedure.

• Renal complications may occur:

 From an excess use of contrast agents.  As a result of emboli or a misplaced stent graft. The radiopaque marker along the edge of the stent

• Inadequate seal zone may result in increased risk of leakage into the aneurysm or migration of the stent graft. Other possible causes of migration are deployment of the proximal spring into a thrombus-filled or severely angled vessel wall.

• Systemic anticoagulation should be used during the implantation procedure based on hospital and physician preferred protocol. If heparin is contraindicated, an alternative anticoagulant should be considered.

• Minimize handling of the constrained endoprosthesis during preparation and insertion to decrease the risk of endoprosthesis contamination and infection.

• Improper placement of the stent graft may also cause an endoleak or occlusion of arteries (other than the renals), which may prevent blood flow necessary to organs and extremities, necessitating surgical removal of the device.

• During general handling of the CoilTrac Delivery System, avoid bending or kinking the introducer sheath (graft cover) because it may cause the Talent Abdominal Stent Graft to prematurely and improperly deploy.

• Never advance or retract the CoilTrac Delivery System from the vasculature without the use of fluoroscopy.

• Do not continue advancing any portion of the delivery system if resistance is felt during advancement of the guidewire or delivery system. Stop and assess the cause of resistance. Vessel or catheter damage may occur. Exercise particular care in areas of stenosis, intravascular thrombosis or in calcified or tortuous vessels.

• The balloon must be DEFLATED before initiating deployment of the stent graft. If resistance is experience during initial deployment, check to ensure that the modeling balloon is completely deflated.

• Do not retract the introducer sheath (graft cover) before placing the delivery system in the proper anatomical position, as this will initiate deployment of the stent graft. The Talent Abdominal Stent Graft cannot be reconstrained or drawn back into the introducer sheath (graft cover), even if the stent graft is only partially deployed. If the introducer sheath (graft cover) is accidentally withdrawn, the device will prematurely deploy and could be placed too high or too low.

• Do not rotate the introducer sheath (graft cover) during deployment, as this may torque the device and cause it to spin on deployment or cause twisting of the iliac limb.

• High pressure injections of contrast media made at the edges of the stent graft immediately after implantation can cause endoleaks.

• When ballooning the stent graft, there is an increased risk of vessel injury and/or rupture, and possible patient death, if the balloon’s proximal and distal radiopaque markers are not completely within the covered (graft fabric) portion of the stent graft.

• Do not exceed maximum inflation diameter (40mm for the 30mm balloon and 20mm for the 20mm balloon). Rupture of the balloon may occur. Adhere to balloon inflation parameters as described in this

graft should be aligned immediately below the lower-most renal arterial origin.

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booklet and on the product label. Over-inflation may result in damage to the vessel wall and/or vessel rupture, or damage to the stent graft.

• Any endoleak left untreated during the implantation procedure must be carefully monitored after implantation.

4.4 Magnetic Resonance Imaging (MRI) Safety Section

MRI may be used on the graft only under specific conditions. See Section 12.5 for details.

5.0 ADVERSE EVENTS

5.1 Observed Adverse Events

The clinical study for the Test Group was a multicenter, prospective study conducted at 13 sites across the US, which included 166 test patients. Major adverse events observed in this study are provided in Section 6.7.

5.2 Potential Adverse Events

Adverse events that may occur and/or require intervention include, but are not limited to:

• Amputation

• Anesthetic complications and subsequent attendant problems (e.g., aspiration)

• Aneurysm enlargement

• Aneurysm rupture and death

• Aortic damage, including perforation, dissection, bleeding, rupture and death

• Arterial or venous thrombosis and/or pseudoaneurysm

• Arteriovenous fistula

• Bleeding, hematoma or coagulopathy

• Bowel complications (e.g., ileus, transient ischemia, infarction, necrosis)

• Cardiac complications and subsequent attendant problems (e.g., arrhythmia, myocardial infarction, congestive

heart failure, hypotension, hypertension)

• Claudication (e.g., buttock, lower limb)

• Death

• Edema

• Embolization (micro and macro) with transient or permanent ischemia or infarction

• Endoleak

• Fever and localized inflammation

• Genitourinary complications and subsequent attendant problems (e.g., ischemia, erosion, fistula, incontinence,

hematuria, infection)

• Hepatic failure

• Impotence

• Infection of the aneurysm, device access site, including abscess formation, transient fever and pain

• Lymphatic complications and subsequent attendant problems (e.g., lymph fistula)

• Neurologic local or systemic complications and subsequent attendant problems (e.g., confusion, stroke,

transient ischemic attack, paraplegia, paraparesis, paralysis)

• Occlusion of device or native vessel

• Pulmonary/respiratory complications and subsequent attendant problems (e.g., pneumonia, respiratory failure,

prolonged intubation)

• Renal complications and subsequent attendant problems (e.g., artery occlusion, contrast toxicity, insufficiency, failure)

• Stent graft: improper component placement; incomplete component deployment; component migration; suture break; occlusion; infection; stent fracture; graft twisting and/or kinking; insertion and removal difficulties; graft material wear; dilatation; erosion; puncture and perigraft flow

• Surgical conversion to open repair

• Vascular access site complications, including infection, pain, hematoma, pseudoaneurysm, arteriovenous

fistula, dissection.

• Vascular spasm or vascular trauma (e.g., iliofemoral vessel dissection, bleeding, rupture, death)

• Vessel damage

• Wound complications and subsequent attendant problems (e.g., dehiscence, infection, hematoma, seroma,

cellulitis)

5.3 Device-Related Adverse Events Reporting

See Section 13.0

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6.0 SUMMARY OF CLINICAL STUDY

6.1 Stent Graft Analysis

The clinical study for the Test Group was a multicenter, prospective study conducted at 13 sites across the US. The Test Group included patients diagnosed with abdominal aortic aneurysms, with or without involvement of the iliac arteries. A total of 166 patients were enrolled in this study. An independent core lab reviewed CT scans and abdominal x-rays to assess aneurysm changes, device position and integrity, and endoleaks. A Clinical Events Committee (CEC) adjudicated Major Adverse Events (MAEs) for the Test Group.

The Control Group (SVS Control) was a compilation of the pivotal open surgical control groups from three approved abdominal aortic aneurysm (AAA) endograft Premarket Approval (PMA) submissions. The SVS Control represented a change from the original IDE protocol, and was used because the SVS Control was more comprehensive than the original IDE Control Group. The data aggregation and analysis were conducted under the auspices of the Society for Vascular Surgery (SVS). Outcomes from a total of 243 patients treated at facilities across the US were included in the SVS Control.

The pivotal analysis included endpoints that were modified from the endpoints listed in the original IDE protocol to endpoints and other metrics that are consistent with current literature and other EVAR clinical studies. The primary safety endpoint for this analysis was the proportion of patients free from a MAE within 30 days of the index procedure (based on a composite MAE rate), compared to the open surgical control. The primary effectiveness endpoint for this analysis was successful aneurysm treatment based on follow-up at pre-discharge, 1 month, 6 months, and 12 months.

6.2 Delivery System Analysis

The analysis of this independent data set supports the clinical performance of the CoilTrac Delivery System, demonstrated by delivery and deployment success rate, as well as, clinically relevant adverse events rates observed within the 30 day post-procedure period.

. Other study endpoints and analyses were presented

Successful aneurysm treatment was a composite endpoint including patients who had technical success (successful delivery and

deployment of the Talent Stent Graft) at the initial procedure and were free from:

• Aneurysm growth > 5mm at 12 months, as evaluated by the core lab; and

• Post-operative interventions to correct Type I/III endoleaks at anytime up to 12 months (Type II endoleaks are generally

considered to be non-device related).

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6.3 Patient Accountability and Follow-Up

For the Test Group, 13 sites enrolled a total of 166 patients. Four (4) patients had technical failure and did not receive a stent graft and therefore did not have any imaging follow-up. 162 patients who received the stent graft were eligible for clinical and imaging follow-up at 1 month follow-up interval. Of these 162 patients, 100% (162/162) had a clinical follow-up and 98.8% (160/162) had imaging follow-up. CT imaging was performed on 96.3% (156/162) patients.

At the 6 month follow-up interval, 152 patients were eligible for clinical and imaging follow-up. Of these, 90.1% (137/152) had clinical follow-up and 81.6 % (124/152) had imaging follow-up. CT imaging was performed on 78.9% (120/152) patients.

At the 12 month follow-up interval, 142 patients were eligible for clinical and imaging follow-up. Of these 97.2% (138/142) had clinical follow-up and 93.0% (132/142) had imaging follow-up. CT imaging was performed on 91.5% (130/142) patients.

Detailed patient accountability and follow-up is provided in Table 2

Table 2: Patient and Imaging Accountability – Test Group

Patient follow-up

Patients with

imaging

performed at

time interval

(Core Lab)

Patients with adequate

imaging to assess the

parameter

Patient events occurring before next

visit

Interval

(Analysis

Window)

Originally

Enrolled

Events after

implant but

before a 1Month

visit

1 Month

(Day 1-90)

Events after 1 Month visit but

before a 6

Month visit

6 Month

(Day 91-304)

Events after 6 Month visit but

before a 12

Month visit

12 Month

(≥ Day 305

Data analysis sample size varies for each of the timepoints above and in the following tables. This variability is due to

Eligible

Clinical

Imaging

Follow-up

CT Imaging

166

162 162 160 156 141

152 137 124 120 103 118 114 120 101

142 138 132 130 112 128 120 128 110

)

0 0 0 0

0 5 5 0

KUB Imaging

Aneurysm

Endoleak

size increase

150 143 136

Migration

Integrity

Failure

Technical

Conversion to

Death

Surgery

Lost to

Withdrawal

patient availability for follow-up, as well as, quantity and quality of images available from specific timepoints for evaluation. For example, the number and quality of images available for evaluation of endoleak at 6 months is different than the number and quality of images available at 12 months due to variation in the number of image exams performed, the number of images provided from the clinical site to the Core Lab, and/or the number of images with acceptable evaluation quality.

In cases where 12 month imaging follow-up data were not available, subsequent imaging follow-up data were used.

Follow-up

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The SVS Control included 243 patients. Detailed patient accountability and follow-up is provided in Table 3 below. At the 1 month follow-up interval, 239 patients were eligible and 98.7% (236/239) had clinical follow-up. At the 6 month follow-up interval, 230 patients were eligible and 90.9% (209/230) had clinical follow-up. At the 12 month follow-up interval, 219 patients were eligible and 97.7% (214/219) had clinical follow-up.

Table 3: Patient Accountability – SVS Control

Interval (Analysis Window)

Originally enrolled 243

Patient follow-up

Eligible

Clinical Follow-

up Death

Patients with events occurring

before next visit

Withdrawal/ Lost

to Follow-up

Events after procedure but before 1 Month visit

1 Month visit (Day 1-90)

Events after 1 Month visit but before 6 Month visit

6 Month visit (Day 91-304)

Events after 6 Month visit but before 12 Month visit

12 Month visit (≥ Day 305)

4 0

239 236

7 2

230 209

5 6

219 214

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6.4 Demographic and Baseline Medical History Data

Table 4 through Table 6 provide the demographics and baseline medical characteristics of the Test Group and SVS Control patients. Medtronic observed that the Test Group was older and had more co-morbidities than the patients within the SVS Control.

Table 4: Patient Demographics, Test Group vs. SVS Control

Parameter Statistics/Category Test Group SVS Control p-value

Age (years)

n 166 243

Mean ± SD 74.1 ± 7.49 70.1 ± 7.49 < 0.001

Median 76.0 70.0

Min, max 51, 89 46, 86

Gender % (m/n)

Male 91.6% (152/166) 81.5% (198/243) 0.004

Ethnicity % (m/n)

White, non-Hispanic 92.8% (154/166) 94.9% (168/177)

Non-White 7.2% (12/166) 5.1% (9/177)

0.501

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Table 5: Baseline Medical History, Test Group vs. SVS Control

Body System / Condition

Cardiovascular

Angina 16.9% (28/166) 17.4% (23/132) > 0.999

Arrhythmia 44.0% (73/166) 11.5% (28/243) < 0.001

Cardiac revascularization2 38.6% (64/166) 46.1% (112/243) 0.154

Congestive heart failure 28.3% (47/166) 4.9% (12/243) < 0.001

Coronary artery disease 56.0% (93/166) 61.3% (149/243) 0.306

Hypertension 83.7% (139/166) 66.7% (162/243) < 0.001

Myocardial infarction 38.6% (64/166) 34.2% (83/243) 0.401

Peripheral vascular disease 46.4% (77/166) 15.6% (38/243) < 0.001

Renal3

Renal insufficiency 54.8% (91/166) N/A N/A

Renal failure N/A 4.1% (10/243) N/A

Test Group

%(m/n) 1

SVS Control

%(m/n) 1 p-value

Neurological3

Cerebral vascular accident 22.9% (38/166) N/A N/A

Cerebrovascular disease N/A 12.8% (31/243) N/A

Other abnormal body systems

Diabetes 15.7% (26/166) 11.9% (29/243) 0.303

Chronic obstructive pulmonary disease 39.2% (65/166) 30.0% (73/243) 0.070

Tobacco use 84.9% (141/166) 85.6% (208/243) 0.887

Denominator is 166 patients in the Test Group and 243 patients in the SVS Control.

Cardiac Revascularization includes Coronary Artery Bypass Grafting (CABG) or PTCA.

SVS Control reported "Renal Failure" and "Cerebrovascular Diseases", but Test Group reported "Renal

Insufficiency” and "Cerebral Vascular Accident", respectively. These categories are not comparable.

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Table 6: Baseline SVS Classification, Test Group Only

SVS Classification

SVS 0 6.0% (10/166)

SVS 1 47.6% (79/166)

SVS 2 41.0% (68/166)

SVS 3 5.4% (9/166)

6.5 Baseline Aneurysm Data

Table 7 through Table 9 provide the baseline aneurysm diameters and morphologies of the Test Group and SVS Control .

Table 7: Baseline Maximum Aneurysm Diameters, Test Group vs. SVS Control (Site Reported)

Aneurysm Characteristics Statistics

n 166 214

Test Group

%(m/n)

Test Group

Site Reported

SVS Control

Site Reported p-value

Maximum aneurysm diameter (mm)

Table 8: Distribution of Baseline Maximum Aneurysm Diameters,

Maximum Aneurysm Diameter

< 30mm 0.0% (0/166) 0.0% (0/214)

30-39mm 0.0% (0/166) 2.3% (5/214)

40-49mm 14.5% (24/166) 21.5% (46/214)

50-59mm 51.8% (86/166) 42.5% (91/214)

60-69mm 22.3% (37/166) 20.1% (43/214)

70-79mm 8.4% (14/166) 8.4% (18/214)

80-89mm 3.0% (5/166) 3.3% (7/214)

≥ 90mm 0.0% (0/166) 1.9% (4/214)

Mean ± SD 57.1±8.49 56.9±11.59 0.826

Median 55.0 54.8

Min, max 43, 87 31, 100

Test Group vs. SVS Control (Site Reported)

Test Group

Site-Reported

%(m/n)

SVS Control

Site-Reported

%(m/n)

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Table 9: Baseline Aneurysm Characteristics, Test Group

Dimension Statistics Site Reported

n 166 156

Core Lab Reported

Maximum aneurysm diameter (mm)

Proximal neck diameter (mm)

Right iliac diameter (mm)

Left iliac diameter (mm)

Proximal neck length (mm)

Mean ± SD 57.1 ± 8.49 55.0 ± 9.26

Median 55 53

Min, Max 43, 87 38, 88

n 165 156

Mean ± SD 25.6 ± 3.35 25.3 ± 3.58

Median 26 26

Min, Max 16, 32 16, 32

n 164 155

Mean ± SD 9.3 ± 1.55 9.2 ± 1.53

Median 9 9

Min, Max 6, 16 6, 14

n 164 155

Mean ± SD 9.3 ± 1.46 9.3 ± 1.55

Median 9 9

Min, Max 6, 14 6, 15

n 166 154

Mean ± SD 23.9 ± 12.88 22.9 ± 12.48

Median 20 21

Min, Max 3, 85 3, 75

n 157 127

Aortic neck angle (°)

Mean ± SD 18.7 ± 15.40 30.5 ± 15.80

Median 19 30

Min, Max 0, 60 0, 72

Page 22

6.6 Devices Implanted

Table 10 provides a breakdown of the number of Talent Abdominal Stent Grafts implanted per patient.

Table 10: Total Number of Talent Abdominal Stent Grafts Implanted at Initial Procedure

Number of Devices Implanted

1 0.0% (0/162)

2 42.0% (68/162)

3 32.7% (53/162)

4 22.2% (36/162)

5 3.1% (5/162)

≥ 6 0.0% (0/162)

Denominator is 162 patients with implanted devices.

Test Group

%(m/n)1

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6.7 Study Results

Results for the safety and effectiveness of the Talent Abdominal Stent Graft are presented in Section 6.8 and 6.9 below.

6.8 Safety

SVS

SVS Control N = 243 % (m/n)

95% Exact

Confidence

Interval of Difference

95% Exact

Confidence

Interval of Difference

2,3

Primary Safety Endpoint: Freedom from MAEs within 30 Days

Through 30 days, patients who received the Talent Abdominal Stent Graft experienced a lower rate of MAEs than patients treated with open surgery. Table 11 and Table 12 provide an analysis of freedom from MAEs within 30 days.

Table 11: Primary Safety Endpoint: Freedom from MAEs within 30 Days, Test Group vs. SVS Control

Test Group Freedom from Major Adverse Event (MAE) within 30 Days

N = 166 % (m/n)

Freedom from MAEs within 30 Days 89.2% (148/166) 44.0% (107/243) (36.9%, 52.6%)

Confidence level was not adjusted for multiplicity. Confidence interval for difference (Test - SVS Control) in

percentage was calculated by the exact method.

Difference represents the (% of patients free from MAEs within 30 days in the population treated with the test

device) - (% of patients free from MAEs within 30 days in the population undergoing open surgical repair)

Table 12: Primary Safety Endpoint: MAE Components within 30 Days, Test Group vs. SVS Control

Major Adverse Event (MAE) within 30 Days1

Test Group

N = 166

%(m/n)

Control N = 243

%(m/n)

1,2

MAE rate at 30 days 10.8%

(18/166)

All-cause Death 1.8%

(3/166)

Myocardial Infarction 1.8%

(3/166)

Renal Failure 1.8%

(3/166)

Respiratory Failure 3.0%

(5/166)

Paraplegia 0.0%

(0/166)

Stroke 1.2%

(2/166)

Bowel Ischemia 0.6%

(1/166)

Procedural Blood Loss ≥ 1000cc 5.4%

(9/166)

A patient may report multiple MAEs; hence, number of patients with any MAE may not be the sum of those in

56.0%

(136/243)

2.9%

(7/243)

5.3%

(13/243)

2.9%

(7/243)

5.8%

(14/243)

0.4%

(1/243)

1.2%

(3/243)

0.0%

(0/243)

51.0%

(124/243)

N/A

(-4.4%, 2.8%)

(-7.6%, 0.4%)

(-4.4%, 2.8%)

(-7.0%, 1.7%)

(-2.3%, 2.0%)

(-2.6%, 3.3%)

(-1.0%, 3.6%)

(-52.6%, -38.1%)

each MAE category.

Confidence level was not adjusted for multiplicity. Confidence intervals for difference (Test - SVS Control) in

percentage were calculated by the exact method.

Difference represents the (% of patients with MAEs within 30 days in the population treated with the test

device) - (% of patients with MAEs within 30 days in the population undergoing open surgical repair)

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Freedom from MAEs within 365 Days

At 365 days, treatment with the Talent Abdominal Stent Graft continued to perform favorably when compared to open surgery. Table 13 and Table 14 provide an analysis of freedom from MAEs at 365 days, and Figure 6 and Table 15 depict the corresponding Kaplan-Meier plot.

Table 13: Freedom from MAEs within 365 Days,

Freedom from MAEs within 365 Days

Freedom from MAEs within 365 Days 80.4% (123/153) 41.7% (100/240) (29.4%, 47.2%)

Confidence level was not adjusted for multiplicity. Confidence interval for difference (Test - SVS Control) in

percentage was calculated by the exact method.

Difference represents the (% of patients free from MAEs within 365 days in the population treated with the test

device) - (% of patients free from MAE within 365 days in the population undergoing open surgical repair)

Test Group vs. SVS Control

Test Group

N = 166

% (m/n)

SVS

Control

N = 243

% (m/n)

95% Exact

Confidence Interval

of Difference

Table 14: MAE Components within 365 Days,

MAEs within 365 Days1

MAE rate at 365 days 19.6% (30/153) 58.3% (140/240) N/A

All-cause Death 6.5% (10/153) 7.5% (18/240) (-6.1%, 5.0%)

Myocardial Infarction 3.9% (6/153) 7.9% (19/240) (-8.9%, 1.4%)

Renal Failure 3.3% (5/153) 2.9% (7/240) (-3.2%, 5.0%)

Respiratory Failure 3.9% (6/153) 6.3% (15/240) (-6.8%, 3.0%)

Test Group vs. SVS Control

Test Group

N = 166

% (m/n)

SVS

Control

N = 243

% (m/n)

95% Exact

Confidence Interval

of Difference

1,2

2,3

Paraplegia 0.0% (0/153) 0.4% (1/240) (-2.4%, 2.2%)

Stroke 2.6% (4/153) 1.7% (4/240) (-2.1%, 5.0%)

Bowel Ischemia 0.7% (1/153) 0.0% (0/240) (-0.9%, 3.9%)

Procedural Blood Loss ≥1000 cc 5.9% (9/153) 51.7% (124/240) (-52.9%, -38.1%)

A patient may report multiple MAEs; hence, number of patients with any MAE may not be the sum of those in

each MAE category.

Confidence level was not adjusted for multiplicity. Confidence intervals for difference (Test - SVS Control) in

percentage were calculated by the exact method.

Difference represents the (% of patients with MAEs within 365 days in the population treated with the test device)

- (% of patients with MAEs within 365 days in the population undergoing open surgical repair)

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Figure 6: Kaplan-Meier Estimates of Freedom from MAEs (0 to 365 Days),

Test Group vs. SVS Control

Note: eLPS, as described in the figure above, refers to the Test Group.

No. at Risk 166 142 136 243 107 105

No. of Events 18 4 8 136 2 2

No. Censored 6 2 8 0 0 7

Kaplan-Meier Estimate 0.891 0.866 0.813 0.440 0.432 0.424

Table 15: Details of Kaplan-Meier Estimates of Freedom from MAEs (0 to 365 Days),

Treatment to 30 days

Test Group vs. SVS Control

Test Group SVS Control

31 days to 182 days

183 days to 365 days

Treatment to 30 days

31 days to 182 days

183 days to 365 days

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Freedom from All-Cause Mortality within 30 Days

Table 16 provides the summary of patients with freedom from all-cause mortality at 30 days for the Test Group and SVS Control.

Table 16: Freedom from All-Cause Mortality within 30 Days,

Test Group vs. SVS Control

95% Exact

Confidence

Interval of

Difference

1,2

Secondary Endpoint

Test Group

%(m/n)

SVS Control %(m/n)

Freedom from All-Cause Mortality

98.2% (163/166) 97.1% (236/243) (-2.8%, 4.4%)

within 30 Days

Confidence level was not adjusted for multiplicity. Confidence interval for difference (Test - SVS Control) in

percentage was calculated by the exact method.

Difference represents the (% of patients free from all-cause mortality within 30 days in the population treated with the test device) - (% of patients free from all-cause mortality within 30 days in the population undergoing open surgical repair)

Freedom from Aneurysm-Related Mortality within 365 Days

Table 17 and Figure 7 provide the analysis and Kaplan-Meier plot of freedom from aneurysm-related mortality at 365 days. Additional detail is provided in Table 18.

Notably, there were no conversions to surgery or aneurysm ruptures in the Test Group within 365 days. See Table 29 for aneurysm rupture results.

Table 17: Freedom from Aneurysm-Related Mortality within 365 Days,

Test Group vs. SVS Control

Secondary Endpoint

Freedom from Aneurysm-Related

Test Group

N = 166 % (m/n)

Control N = 243 % (m/n)

97.9% (143/146) 96.4% (217/225) (-2.8%, 5.4%)

SVS

95% Exact

Confidence

Interval of

Difference

1,2

Mortality within 365 Days

Confidence level was not adjusted for multiplicity. Confidence interval for difference (Test - SVS Control) in percentage was calculated by the exact method.

Difference represents the (% of patients free from aneurysm-related mortality within 365 days in the population treated with the test device) - (% of patients free from aneurysm-related mortality within 365 days in the population undergoing open surgical repair)

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Figure 7: Kaplan-Meier Estimates of Freedom from Aneurysm-Related Mortality within 365 Days,

Test Group vs. SVS Control

Note: eLPS, as described in the figure above, refers to the Test Group.

Table 18: Details of Kaplan-Meier Estimates of Freedom from Aneurysm-Related Mortality within 365 Days,

No. at Risk 166 157 151 243 232 227

No. of Events 3 0 0 7 1 0

No. Censored 6 6 12 4 4 21

Kaplan-Meier

Estimate 0.982 0.982 0.982 0.971 0.967 0.967

Treatment to 30 days

Test Group vs. SVS Control

Test Group SVS Control

31 days to

182 days

183 days to

365 days

Treatment to 30 days

31 days to

182 days

183 days to

365 days

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Freedom from All-Cause Mortality within 365 Days

Table 19 and Figure 8 provide the analysis and Kaplan-Meier plot of freedom from all-cause mortality at 365 Days. Additional detail is provided in Table 20.

Table 19: Freedom from All-Cause Mortality within 365 Days, Test Group vs. SVS Control

95% Exact

Confidence

Interval of

Difference

1,2

Related Analysis

Test Group

% (m/n)

SVS Control % (m/n)

Freedom from All-Cause Mortality within 365 Days

Confidence level was not adjusted for multiplicity. Confidence interval for difference (Test - SVS Control) in

percentage was calculated by the exact method.

Difference represents the (% of patients free from all-cause mortality within 365 days in the population treated with the test device) - (% of patients free from all-cause mortality within 365 days in the population undergoing open surgical repair)

93.5% (143/153) 92.5% (222/240) (-5.0%, 6.1%)

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Figure 8: Kaplan-Meier Estimates of Freedom from All-Cause Mortality within 365 Days,

Test Group vs. SVS Control

Note: eLPS, as described in the figure above, refers to the Test Group.

Table 20: Details of Kaplan-Meier Estimates of Freedom from All-Cause Mortality within 365 Days,

Test Group vs. SVS Control

Test Group SVS Control

No. at Risk 166 157 151 243 232 227

No. of Events 3 3 4 7 4 7

No. Censored 6 3 8 4 1 14

Kaplan-Meier

Estimate 0.982 0.963 0.937 0.971 0.954 0.924

Treatment to 30 days

31 days to

182 days

183 days to

365 days

Treatment to 30 days

31 days to

182 days

183 days to

365 days

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6.9 Effectiveness

Primary Effectiveness Endpoint: Successful Aneurysm Treatment

The primary effectiveness endpoint, successful aneurysm treatment, was a composite endpoint including patients who had technical success (successful delivery and deployment of the Talent Stent Graft) at the initial procedure and were free from:

• Aneurysm growth > 5mm at 12 months, as evaluated by the core lab; and

• Post-operative interventions to correct Type I/III endoleaks at anytime up to 12 months (Type II endoleaks

are generally considered to be non-device related).

Other clinically relevant measures (see Table 23 through Table 30) of stent graft effectiveness were also evaluated and are provided separately in the sections below.

As shown in Table 21, the Talent Abdominal Stent Graft achieved a successful aneurysm treatment rate of 90.2%. Table 22 provides details regarding patients who have failed the successful aneurysm treatment endpoint.

Table 21: Primary Effectiveness Endpoint: Successful Aneurysm Treatment, Test Group

Primary Effectiveness Endpoint

Successful Aneurysm Treatment 90.2% (110/122) (83.4%, 94.8%)

Confidence level was not adjusted for multiplicity. Confidence interval for the percentage was

calculated by the exact (binomial) method.

Test Group

%(m/n)

95% Exact

Confidence

Interval

Table 22: Primary Effectiveness Endpoint: Successful Aneurysm Treatment, Test Group

Test Group

Patients with Primary Effectiveness Failure

%(m/n)

Unsuccessful (Failure) Aneurysm Treatment 9.8% (12/122)

Technical Failure

3.3% (4/122)

Aneurysm Growth > 5mm at 12 Months (Core Lab) 2.5% (3/122)2

Post-Operative Interventions To Correct Type I/III Endoleaks 4.1% (5/122)

All four technical failures were due to access difficulties. Note: These failures were associated

with a prior iteration delivery system.

Of these three patients, two died at day 600 and 692, respectively. One patient death was attributed to a possible device–related cause (patient refused further treatment). No additional adverse events were identified with the other patient death.

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Other Effectiveness Data

Migration-Free at 12 Months1 99.2% (128/129) 2 (95.8%, 100.0%)

Migration is defined as evidence of proximal or distal movement of the stent graft > 10mm relative to fixed anatomic landmarks.

At three-year follow-up, the patient was admitted for endovascular repair of Type I endoleak (proximal).

Confidence level was not adjusted for multiplicity. Confidence interval for the percentage was calculated by the exact (binomial) method.

Stent Graft Patency at 12 Months 100.0% (120/120) (97.0%, 100.0%)

Confidence level was not adjusted for multiplicity. Confidence interval for the percentage was calculated by the exact (binomial) method.

Table 23: Migration-Free at 12 Months, Test Group (Core Lab)

Test Group

Other Effectiveness Data

%(m/n)

Table 24: Stent Graft Patency at 12 Months, Test Group (Core Lab)

Test Group

Other Effectiveness Data

%(m/n)

95% Exact

Confidence

Interval3

95% Exact

Confidence

Interval 1

Table 25: Freedom from Secondary Endovascular Procedures within 365 Days, Test Group

Test Group

Other Effectiveness Data

Secondary Endpoint: Freedom from Secondary Endovascular Procedures within 365 days

The 5 patients who received a secondary endovascular procedure are characterized as follows:

Three (3) patients had endoleaks detected at day 1, 1, and 32, with secondary procedures at Day 69, 74, and 95, respectively. Aortic cuffs were placed to correct Type I endoleaks (proximal). Repairs were successful.

One (1) patient had endoleak detected at day 103, with a secondary procedure at day 168. Two (2) iliac limb extensions were placed to correct the Type I endoleak (distal). Repair was successful.

One (1) patient had graft-blush detected post-procedure, with a secondary procedure at day 183. An aortic cuff and iliac extension were placed to correct graft blush and stitch hole endoleak. Repair was successful.

Confidence level was not adjusted for multiplicity. Confidence interval for the percentage was calculated by the exact (binomial) method.

%(m/n)

96.5% (138/143) 1 (92.0%, 98.9%)

95% Exact

Confidence

Interval 2

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Table 26: Loss of Stent Graft Integrity at 12 Months, Test Group (Core Lab)

95% Exact

Other Effectiveness Data

Test Group

%(m/n)

Confidence

Interval3

Loss of Stent Graft Integrity at 12 Months1 2.7% (3/110)2 (0.6%, 7.8%)

Loss of stent graft integrity is defined as the occurrence of stent graft wire and/or connecting bar fracture. Of these 3 patients, 2 had a connecting bar fracture – one at the proximal main body and the other at the level of the left iliac (source for locations is patient files). The third patient had a graft wire fracture, located on the second spring row at the proximal aspect of the graft.

Of the 3 patients with loss of stent graft integrity, one patient expired at approximately 2 years due to stroke (CVA). The stent graft did not cause or contribute to the patient death. Another patient had no endoleak reported at the 1, 6 or 12 month visits. At the 4 year follow-up there were no endoleaks reported. The remaining patient withdrew from the study 2 years and four months following the procedure. This patient had no clinical sequelae reported during follow-up.

Confidence level was not adjusted for multiplicity. Confidence interval for the percentage was calculated by the exact (binomial) method.

Table 27: Type I/III Endoleak-Free at 12 Months, Test Group (Core Lab)

Test Group

Other Effectiveness Data

Endoleak-Free (Type I/III) at 12 Months1 93.4% (113/121)

Endoleak-free (Type I/III) at 12 months is defined as patients who did not have Type I/III

%(m/n)

2, 3

(87.4%, 97.1%)

endoleak at 12 months time point and did not have a secondary endovascular intervention to treat a Type I/III endoleak.

The 8 patients that were not endoleak-free, include 5 patients that required a secondary endovascular procedure to treat their endoleaks (previously referenced in Table 22 and Table 25) and 3 patients that did not require secondary procedures.

One (1) patient had a secondary procedure to correct an endoleak at 6 months post implant. However this patient was not assessable for endoleak at the 12 month follow-up visit. This represents an increase of 1 in the denominator in the above table as compared to the number of patients assessable for endoleaks in Table 2

Confidence level was not adjusted for multiplicity. Confidence interval for the percentage was calculated by the exact (binomial) method.

95% Exact

Confidence

Interval4

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Table 28: Summary of All Endoleaks at 1 Month and 12 Months, Test Group (Core Lab)

Core Lab

Endoleaks at 12 Months

Endoleaks of any type 19.3% (29/150) 9.2% (11/120)

Type I 9.3% (14/150) 2.5% (3/120)

Type II 8.7% (13/150) 5.8% (7/120)

Type III 0.0% (0/150) 0.0% (0/120)

Type IV 0.0% (0/150) 0.0% (0/120)

Indeterminate 1.3% (2/150) 0.8% (1/120)

Endoleaks reported are not cumulative but represent the number of endoleaks present at each time point.

Of these 3 patients, one patient withdrew from the study (post a three year follow-up) prior to a secondary procedure to treat the endoleak. For the remaining two patients no secondary procedures were reported and no additional clinical sequelae were reported. All three Type I endoleaks at 12 months were persistent from a previous follow-up visit, of which one was a secondary endoleak.

The 5 patients that required secondary procedures to treat their endoleaks (previously referenced in Table 22 and Table 25) are not captured in this table because their endoleaks had been resolved prior to the 12 month time point.

Reported at

1 Month1

%(m/n)

Core Lab

Reported at

12 Months1

%(m/n)

2,3

Page 34

Table 29: Aneurysm Rupture within 365 Days, Test Group

Test Group

Other Effectiveness Data

Aneurysm rupture within 365 days post implantation 0.0% (0/143) (0.0%, 2.5%)

Confidence level was not adjusted for multiplicity. Confidence interval for the percentage was

calculated by the exact (binomial) method.

Table 30: Aneurysm Change from 1 Month to 12 Months,

Test Group (Core Lab and Site-Reported)

%(m/n)

Change in Maximum Aneurysm Diameter from 1 Month

Increase More than 5mm 4.5% (6/133) 2.3% (3/128)

Stable1 60.9% (81/133) 64.1% (82/128)

Decrease More than mm 34.6% (46/133) 33.6% (43/128)

Stable refers to no change (increase or decrease) of more than 5 mm.

to 12 Months

Site Reported

%(m/n)

Core Lab Reported

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95% Exact

Confidence

Interval1

%(m/n)

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6.10 Acute Procedural Data

As shown below, the clinical utility measures of the Talent Abdominal Stent Graft are improved as compared to surgery with respect to procedure duration, blood loss, length of time in the ICU and hospital, and usage of general anesthesia. See Table 31 for further information.

Acute Procedural Data Statistics Test Group SVS Control

Table 31: Acute Procedural Data, Test Group and SVS Control

95% Confidence

Interval of

Difference

N 166 241

1,2

Duration of procedure (min)

Contrast Use (cc)

Patients receiving general anesthesia

Estimated blood loss (cc)

Patients requiring blood transfusion

Time in ICU (hours)

Mean ± SD 167.3 ± 53.17 196.4 ± 82.99 (-43.5, -14.8)

Median 155.0 180.0

Min, max 85, 417 57, 498

N 163

Mean ± SD 152.7 ± 81.50

Median 150.0

Min, max 15, 370

% (m/n) 40.4% (67/166) 98.7% (222/225) (-65.7%, -50.4%)

N 165 241

Mean ± SD 335.0 ± 282.36 1347.5 ± 1346.91

Median 250.0 1000.0 (-800.0, -600.0)

Min, max 25, 1750 50, 10763

% (m/n) 18.2% (30/165) 56.8% (75/132) (-48.6%, -28.0%)

N 166 243

Mean ± SD 19.3 ± 73.88 74.3 ± 178.41

Median 0.0 36.0

Min, max 0, 864 0, 1728

n 166 225

Overall hospital stay (days)

Confidence level was not adjusted for multiplicity. Confidence intervals for difference (Test-SVS Control) in means were calculated using a t-distribution. Confidence intervals for difference (Test-SVS Control) in percentages were calculated by the exact method. Confidence intervals for difference (Test-SVS Control) in medians were calculated using Hodges-Lehmann estimation of location shift. Confidence interval for Time in ICU is not calculated due to a large number of ties in the data (i.e. large number of “0 hours” reported in the Test Group).

For Duration of Procedure and Overall Hospital Stay, difference represents the (mean of specific acute procedural parameter in the population treated with the test device) - (mean of specific acute procedural parameter in the population undergoing open surgical repair). For Patients Receiving General Anesthesia and Patients Requiring Blood Transfusion, difference represents the (% of patients with the specific acute procedural parameter for the population treated with the test device) - (% of patients with the specific acute procedural parameter for the population undergoing open surgical repair). For Estimated Blood Loss, difference represents the median shift of estimated blood loss between the two treatment groups (Test-SVS Control).

Mean ± SD 3.6 ± 6.38 8.2 ± 7.97 (-6.1, -3.2)

Median 2.0 6.0

Min, max 1, 79 0, 72

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6.11 CoilTrac Delivery System Performance Data

6.11.1 Delivery and Deployment Success

Subsequent to enrollment in the pivotal trial, the delivery system was updated to the CoilTrac Delivery System. In order to evaluate the clinical performance of the CoilTrac Delivery System, a single-center cohort of 137 patients from an independent data set was evaluated. The analysis of this independent data set supports the clinical performance of the CoilTrac Delivery System, demonstrated by delivery and deployment success rate, as well as, clinically relevant adverse events rates observed within the 30 day post-procedure period.

Table 32 presents the rate of successful delivery and deployment of the Talent Abdominal Stent Graft using the CoilTrac Delivery System. A 100% success rate was achieved in 137 patients treated. Successful delivery and deployment was defined as an initial successful implant procedure that was not aborted and did not involve delivery system malfunction.

Table 32: CoilTrac Delivery System: Delivery and Deployment Success

Device

Performance Measure

(Site-Reported)

N = 137 % (m/n)

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95% Exact

Confidence Interval

Talent Abdominal Stent Graft with the CoilTrac Delivery System

Confidence level was not adjusted for multiplicity. Confidence interval for the percentage was calculated by

the exact (binomial) method.

Successful Stent Graft Delivery and Deployment

100.0% (137/137) (97.3%, 100.0%)

6.11.2 Clinically Relevant Adverse Events Within 30 Days

Table 33 presents the clinically relevant adverse events occurring intra-and peri-operatively for the patients implanted with the Talent Abdominal Stent Graft using the CoilTrac Delivery System.

The overall rate of patients with at least one clinically relevant adverse event is 15.3% (21/137) with a two-sided 95% exact confidence interval (9.7%, 22.5%). There were no reports of rupture, surgical conversion, branch vessel occlusion or migration.

Table 33: CoilTrac Delivery System: Patients with Clinically Relevant Adverse Events [Within 30 Days]

Category

All-cause mortality 1.5% (2/137) 1

AAA rupture 0.0% (0/137)

Conversion to open repair 0.0% (0/137)

Branch vessel occlusion: renal artery/superior mesenteric artery 0.0% (0/137)

Stent graft occlusion 1.5% (2/137)

N = 137

%(m/n)

Stent graft migration 0.0% (0/137)

Device-specific endoleaks 8.8% (12/137) 2

Access site wound infection 2.2% (3/137)

Access site wound hematoma 3.6% (5/137)

Both deaths were unrelated to the aneurysm, procedure, or device.

Type I endoleak = 7 patients, Type III endoleak = 0 patients, Unknown Type endoleak = 5 patients

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7.0 PATIENT SELECTION

7.1 Individualization of Treatment

Medtronic recommends that the Talent Abdominal Stent Graft System component diameters be selected as described in Table 34. The length of the Talent Abdominal Stent Graft should extend from the distal edge of the lowest renal artery to just above the origin of the internal iliac (hypogastric) artery. In addition, the aortic length should be > 1.0cm longer than the main body portion of the chosen bifurcated model. All lengths and diameters of the devices necessary to complete the procedure should be available to the physician, especially when preoperative case planning measurements (treatment diameters/lengths) are not certain. This approach allows for greater intraoperative flexibility to achieve optimal procedural outcomes. The warnings and precautions previously described in Section 4.0 should be carefully considered relative to each patient before use of the Talent Stent Graft System. Additional considerations for patient selection include, but are not limited to:

• Patient's age and life expectancy

• Co-morbidities (e.g., cardiac, pulmonary or renal insufficiency prior to surgery, morbid obesity)

• Patient's suitability for open surgical repair

• Patient's anatomical suitability for endovascular repair

• The risk of aneurysm rupture compared to the risks of endovascular repair

• Ability to tolerate general, regional or local anesthesia

• Iliofemoral access vessel size and morphology (minimal thrombus, calcium and/or tortuosity) should

be compatible with vascular access techniques of the various delivery catheter profiles. The Talent Abdominal Stent Graft System is delivered through a vascular introducer sheath (graft cover).

• Adequate iliac/femoral access compatible with the required delivery systems (a diameter of > 7 mm)

• Non-aneurysmal aortic neck between the renal arteries and the aneurysm:

• Common iliac artery distal fixation site:

• Freedom from significant femoral/iliac artery occlusive disease that would impede flow through the

The final treatment decision is at the discretion of the physician and patient.

8.0 PATIENT COUNSELING INFORMATION

The physician should consider the following points when counseling the patient about this endovascular device and procedure:

• Differences between endovascular repair and open surgical repair

• Risks related to open surgical repair

• Risks related to endovascular repair

• Risks related to non-interventional treatment (medical management)

• Pros and cons of open surgical repair and endovascular repair, including the fact that endovascular repair

possesses potential advantages related to its minimally invasive approach. It is possible that subsequent endovascular or open surgical repair of the aneurysm may be required. Regular follow-up, including imaging of the device, should be performed as recommended in Table 36 (Section 12.0), or more frequently in patients with enhanced surveillance needs.

• The long term effectiveness of endovascular repair has not been established

• Symptoms of aneurysm rupture

• Further counseling information can be found in the Patient Information Booklet

Medtronic recommends that physicians use the Medtronic Patient Information Booklet to aid in describing risks associated with use of the Talent Abdominal Stent Graft System with the patient. Additionally Medtronic recommends that detailed patient specific risks also be discussed.

9.0 HOW SUPPLIED

9.1 Contents

The Talent Abdominal System components are available in the configurations identified in Section 15.0.

In addition to the device, each carton contains:

• One (1) set of patient tracking materials

• One (1) instructions for use reference

 A proximal aortic neck length of > 10mm  Proximal aortic neck angulation ≤ 60°  An aortic diameter of 18–32mm

 Distal iliac artery fixation length of >  Iliac artery diameters of 8–22mm

vascular graft.

15mm

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9.2 Sterility and Storage

• Never attempt to resterilize a Talent Abdominal Stent Graft or CoilTrac Delivery System. Resterilization may adversely affect the proper mechanical function of the stent graft or delivery system and could result in patient injury and/or conversion to an open surgical procedure.

• For single use only. Delivery systems are disposable; do not reuse.

• Store at room temperature in a dark, dry place

10.0 CLINICAL USE INFORMATION

10.1 Recommended Skills and Training

Physicians using the Talent Abdominal Stent Graft System must be trained in vascular interventional procedures and in the use of this device.

The recommended skill/knowledge requirements for physicians using the Talent Abdominal Stent Graft System are outlined below:

10.1.1 Patient selection:

• Knowledge of the natural history of abdominal aortic aneurysms and comorbidities associated with

• Knowledge of image interpretation, stent graft selection and sizing.

10.1.2 Physician skills and experience

Either the individual physician operator or a combined, multidisciplinary team should possess extensive procedural skills and experience with:

• Femoral cutdown, arteriotomy, and repair;

• Non-selective and selective catheterization;

• Live fluoroscopic and angiographic image interpretation;

• Embolization;

• Angioplasty;

• Endovascular stent graft placement;

• Snare techniques;

• Appropriate use of contrast material; and

• Techniques to minimize radiation exposure.

abdominal repair; and

10.2 Material Recommended for Device Implantation

At the time of surgery, it is recommended that physicians have available:

• At least one additional set of Talent Abdominal Stent Grafts (of the sizes intended for implantation) in the event that a device is contaminated or damaged during attempted placement

• Additional Talent Abdominal Stent Grafts (one size larger and one size smaller) in the event that the original measurement underestimated or overestimated vessel sizes

• Additional aortic and iliac extension cuffs of various lengths and diameters to customize the implant in order to fit the anatomy of the individual patient

• Fluoroscope with digital angiography capabilities and the ability to record and recall imaging

• Contrast media

• Introducer sheaths for vascular access to access arteries and to perform diagnostic imaging

• Assorted angiographic catheters, angioplasty catheters, graduated pigtail catheters

• Assorted guidewires

• Reliant® Stent Graft Balloon Catheter and other materials recommended by the Reliant Instructions for

Use

• Heparin and heparinized saline solution

• Sterile lubricant

• Surgical instruments and supplies

10.3 Pre-Treatment Planning

Correct sizing of the aorta and iliac vessels must be determined before implantation of the Talent Abdominal Stent Graft System. Medtronic Vascular recommends using spiral computer aided tomography (CT) as well as angiograms of both the iliacs and aorta. These images should be available for review during the procedure.

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Each Talent Abdominal Stent Graft System must be sized appropriately to fit the patient's anatomy. Sizing must be to the vessel wall, not thrombus. Proper sizing of the device is the responsibility of the physician. See the recommended oversizing guidelines in Table 34.

• Vessel over-distension and damage may be caused by excessive oversizing of the stent graft in relation to the diameter of the blood vessel.

• Undersizing of the stent graft may lead to device migration and/or endoleaks.

Physicians may consult Medtronic Vascular for guidance in determining proper device dimensions based on the physician's assessment of the patient's anatomical measurements.

Relevant materials should be readily available as listed in Section 10.2. Cutdown and vessel access are required and in some cases vessel by-pass may be required. A vascular surgical team should be readily available (i.e., within the same facility) in case of emergency conversion to an open surgical repair.

To reduce the risk of thromboembolism, it is recommended that patients are anticoagulated during the procedure, at the discretion of the physician.

If necessary, open narrow iliac vessels with standard Percutaneous Transluminal Angioplasty (PTA) catheters prior to Talent Abdominal Stent Graft System placement (according to standard endovascular procedures). If necessary, dilate the vessel with a tapered vessel dilator. A step-up approach is recommended for vessel dilation.

Table 34: Talent Abdominal Stent Graft System Oversizing Guidelines

(mm)

8 8

9-10 10 11-12 12 13-14 14

15 16 16-17 18 18-19 20 22 20-21 22 24

22 24

23 24-25 28 26-27 30 28-29 32 30-31 34

Recommended Talent Diameter (mm) Native Vessel Diameter

Iliac Aorta

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11.0 DIRECTIONS FOR USE – STENT GRAFT SYSTEM

11.1 Pictorial References

For pictorial references of the Talent Abdominal Stent Graft components and CoilTrac Delivery System, refer to Figure 1 and Figure 5 respectively.

11.2 Vascular Access and Arteriotomy

Following aseptic procedural guidelines perform arteriotomies at the access sites. Place a guidewire in the ipsilateral femoral artery and advance it above the renal arteries. From the contralateral side femoral artery, place a second guidewire directed to the abdominal aorta. Over the guidewire, place an angiography catheter above the renal arteries.

11.3 Implantation of the Bifurcated Stent Graft

11.3.1 Preparation of the CoilTrac Delivery System

11.3.1.1 Carefully inspect the sterile package for damage or defects before opening. Do not use product after the “Use By” date on the package. If the integrity of the sterile package has been compromised or the packaging or product is defective, do not use the product. Contact your Medtronic Vascular representative for return information.

11.3.1.2 Remove the package transport wire from the catheter tip. Then, hold the push rod firmly and draw the introducer sheath (graft cover) back a few millimeters (no more than 5mm) to loosen the fit between the graft cover and the stent graft.

11.3.1.3 Prepare balloon.

11.3.1.3.1 Connect an inflation device to the opened stopcock on the balloon inflation port. Draw a

vacuum on the balloon and close the stopcock.

11.3.1.3.2 Fill the inflation device with heparinized saline solution and open the stopcock.

11.3.1.3.3 Hold the catheter with the distal tip and balloon pointing down.

11.3.1.3.4 Partially inflate the balloon.

11.3.1.3.5 Draw back on the inflation device to deflate the balloon.

11.3.1.3.6 Repeat steps 11.3.1.3.3 through 11.3.1.3.5 until all air in the balloon is removed. Each time

these steps are repeated, more air is displaced with liquid. Some changes in the catheter orientation may be necessary to vent all the air.

11.3.1.3.7 When all air in the balloon has been removed, draw a vacuum in the balloon (using the

connected inflation device) and close the stopcock.

CAUTION: Ensure a vacuum is drawn on the balloon before proceeding, as pressure in the balloon could interfere with deployment of the stent graft.

11.3.1.4 Connect a syringe filled with heparinized saline solution to the stopcock on the sideport extension and open the stopcock.

11.3.1.5 While holding the device upright, flush the introducer sheath (graft cover) with the heparinized saline solution (tapping the sheath to aid in releasing air bubbles). Close the stopcock and remove the syringe. Always leave the stopcock closed when not in use.

11.3.1.6 Connect a syringe filled with heparinized saline solution to the guidewire exit port. Flush the guidewire lumen with the heparinized saline solution and remove the syringe.

11.3.1.7 Re-seat the tip by holding the sheath hub firmly and pulling back on the guidewire lumen until a smooth transition with the sheath and tip is achieved. Place the cup plunger such that the distal stent graft spring is encapsulated in the cup plunger. Tighten the tuohy borst valve.

CAUTION: When re-seating the tip, ensure that the proximal graft spring does not overlap the radiopaque “bullet”. This may prevent the stent graft from deploying properly.

11.3.2 Align the stent graft radiopaque markers with the patient’s anatomy

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CAUTION: Never advance or retract the CoilTrac Delivery System from the vasculature without the use of fluoroscopy.

CAUTION: Do not continue advancing any portion of the delivery system if resistance is felt during advancement of the guidewire or delivery system. Stop and assess the cause of resistance. Vessel or catheter damage may occur. Exercise particular care in areas of stenosis, intravascular thrombosis or in calcified or tortuous vessels.

CAUTION: Never use the pushrod to advance the delivery system through the patient’s anatomy; this may cause inadvertent deployment. The Talent Abdominal Stent Graft cannot be reconstrained or drawn back into the introducer sheath (graft cover), even if the stent graft is only partially deployed. The sheath hub should be used to advance the system.

CAUTION: When aligning the position of the CoilTrac Delivery System so that the Talent Abdominal Stent Graft is in proper position for deployment within the vessel, BE SURE THAT THE FLUOROSCOPE IS ANGLED PERPENDICULARLY TO THE CENTER LINE OF THE INFRARENAL AORTA TO AVOID PARALLAX OR OTHER SOURCES OF VISUALIZATION ERROR. ALIGN THE TARGET AREA/FIXATION ZONE (E.G., NECK) IN THE CENTER OF THE FIELD. Some cranial-caudal angulation of the I-I tube may be necessary to achieve this, especially if there is anterior angulation of the aneurysm neck.

11.3.2.1 Before inserting the device into the vasculature, visualize the radiopaque markers on the stent graft to identify positioning of the device within the sheath.

11.3.2.2 Alignment

Turn the delivery system to align the marker on the short stub leg with the patient's contralateral iliac artery

11.3.3 Introduce System

11.3.3.1 Advance the delivery system over the guidewire so that the most proximal spring of the stent graft and the radiopaque markers are visualized at the target location in the proximal aortic neck (Figure

9).

Figure 9: Position the System

11.3.3.2 Inject contrast media into the abdominal aorta and mark the position of the target location, either on the imaging screen or on the patient's body. Adjust the position of the stent graft such that the top edge of the graft fabric, as indicated by two radiopaque markers, is just below the lowest renal artery.

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NOTE: Contrast media may be injected to identify the location of the lower renal artery and verify the position before fully deploying the device. Once the proper proximal position has been identified, do not move the patient or imaging equipment. The angiographic catheter can be removed prior to deployment. However, if the angiographic catheter is not removed until after deployment, ensure that the tip is straightened (pigtail catheter) with a guidewire before removal so that the stent graft is not pulled down.

CAUTION: Before initial deployment, position the stent graft slightly higher than the targeted location.

NOTE: Conformance of the Talent Abdominal Stent Graft to the morphology of a patient’s vasculature is enhanced when

the connecting bar is oriented on the outside of the most severe bend of the vessel.

CAUTION: Failure to seat the plunger against the stent graft end may result in incorrect positioning.

WARNING: The balloon must be DEFLATED before initiating deployment of the stent graft. If resistance is experienced during initial deployment, check to ensure that the modeling balloon is completely deflated.

CAUTION: Never advance the push rod; use sufficient resistance only to hold it stationary. Do not rotate the introducer sheath (graft cover) during deployment.

CAUTION: Do not retract the introducer sheath (graft cover) before placing the delivery system in the proper anatomical position, as this will initiate deployment of the stent graft. The Talent Abdominal Stent Graft cannot be reconstrained or drawn back into the introducer sheath (graft cover), even if the stent graft is only partially deployed. If the introducer sheath (graft cover) is accidentally withdrawn, the device will prematurely deploy and could be placed too high or too low.

11.3.3.3 Confirm Position

Ensure that the distal portion of the contralateral stub leg is above the aortic bifurcation and within the aneurysmal sac, and not within the iliac vessel. Rotate the delivery system until the radiopaque marker on the distal-most spring of the short leg is aligned with the contralateral iliac artery

11.3.4 Deploy Proximal End

11.3.4.1 Prior to drawing back the introducer sheath (graft cover) to deploy the stent graft, verify that the end of the push rod plunger is firmly positioned against the bottom of the stent graft and that the tuohy borst valve is tightened. Under fluoroscopy, proper positioning is indicated by a clearance of approximately 1mm between the push rod coil spring and stent graft distal spring.

11.3.4.2 Prior to deployment, at the discretion of the physician it may be appropriate to decrease the patient's blood pressure to avoid inadvertent displacement of the stent graft upon withdrawal of the sheath.

11.3.4.3 Verify that the balloon is deflated. Holding the push rod stationary with one hand while slowly withdrawing the introducer sheath (graft cover) with the other hand, align the introducer sheath (graft cover) marker band with the middle of the radiopaque bullet. This will indicate that the balloon is free of the introducer sheath (graft cover) and the stent graft is positioned for deployment.

11.3.4.4 Hold the push rod stationary with one hand while slowly withdrawing the introducer sheath (graft cover) with the other hand until the two proximal-most springs are past the introducer sheath (graft cover) radiopaque marker.

11.3.4.5 Use angiography to verify the position of the stent graft in relation to the renal arteries. If the stent graft position is too high, loosen the tuohy borst valve and pull down on the guidewire lumen only, see Figure 10. This will pull the entire system down. Verify that the balloon is deflated before pulling down. Ensure that the distal edge of the contralateral stub leg of the bifurcated stent graft remains above the aortic bifurcation.

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Figure 10: Deploy the Proximal End

11.3.5 Deploy Distal End

11.3.5.1 After confirming the correct position of the stent graft, also confirm that the push rod's cup plunger is still encapsulating the bottom of the stent graft. Under fluoroscopy, proper positioning is indicated by a clearance of approximately 1mm between the push rod coil spring and stent graft distal spring. Tighten the tuohy borst valve.

11.3.5.2 Once the proximal end of the stent graft has been positioned, continue to withdraw the introducer sheath (graft cover) until the distal spring is released from the plunger. If the distal spring does not fully release from the plunger, slowly rotate (less than 90 millimeters until the distal-most spring releases from the plunger. See Figure 11.

CAUTION: Do not rotate the introducer sheath (graft cover) during deployment, as this may torque the device and cause it to spin on deployment or cause twisting of the iliac limb.

) and pull back on the push rod a few

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Figure 11: Deploy the Distal End

11.3.6 Angiogram

11.3.6.1 Using angiography, determine if any endoleaks are present, and verify the position of the implanted stent graft.

CAUTION: High pressure injections of contrast media made at the edges of the stent graft immediately after implantation can cause endoleaks.

If endoleaks are detected, they should be treated by using the balloon to model the stent graft against the vessel wall. See Section 11.3.7. A minor endoleak that does not seal after re-ballooning may seal spontaneously within several days. Major endoleaks that cannot be corrected by ballooning may be corrected by adding a Talent Abdominal Stent Graft extension cuff to the previously placed stent graft. Placing an extension immediately is the most reliable course of endoleak management for both minor and major endoleaks.

If balloon modeling of the stent graft is not performed, proceed to Section 11.3.8.

11.3.7 Balloon Modeling of Stent Graft

11.3.7.1 Open the tuohy borst valve (turn counter-clockwise) to allow free movement of the guidewire lumen.

11.3.7.2 Move the guidewire lumen distally until the balloon is within the first covered spring.

WARNING: When ballooning the stent graft, there is an increased risk of vessel injury and/or rupture, and possible patient death, if the balloon’s proximal and distal radiopaque markers are not completely within the covered (graft fabric) portion of the stent graft.

11.3.7.3 Open the stopcock on the inflation port. Inflate the balloon to firmly model the proximal covered spring, see Figure 12. Using fluoroscopy, watch for stent graft movement. Proper modeling should show very slight outward expansion of stent graft with balloon inflation. Be careful not to over inflate-stop inflation upon observation of stent graft expansion. Over inflation of balloon can cause graft tears and/or vessel dissection or rupture.

WARNING: Do not exceed maximum inflation diameter (40mm for the 30mm balloon and 20mm for the 20mm balloon). Rupture of the balloon may occur. Adhere to balloon inflation parameters as described in this booklet and on the product label. Over-inflation may result in damage to the vessel wall and/or vessel rupture, or damage to the stent graft.

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NOTE: Care should be taken when inflating the balloon, especially with calcified, tortuous, stenotic, or otherwise diseased vessels. Inflate slowly. It is recommended that a backup balloon be available.

CAUTION: Table 35 is only a guide. Balloon expansion should be carefully monitored with the use of fluoroscopy.

The table below is a guideline for determining the volume of solution (25% contrast/ 75% saline is recommended) required to obtain a given balloon expansion diameter:

11.3.7.4 Fully deflate balloon. If further modeling is required, move the balloon distally to the next location requiring modeling. Inflate the balloon to firmly model the spring to the aortic wall. Using fluoroscopy, watch for stent graft movement. Proper modeling should show very slight outward expansion of the stent graft with balloon inflation. Over inflation of balloon can cause graft tears and/or vessel dissection or rupture.

11.3.7.5 As necessary, repeat steps 11.3.7.3 and 11.3.7.4 until the entire stent graft has been modeled.

Table 35: Guideline for balloon diameter to volume

20mm Balloon 30mm Balloon

Diameter CC's (ml)1 Diameter CC's (ml)1

10mm 2 10mm 2

15mm 3 20mm 6

20mm 5 30mm 15

-- -- 40mm 31

Syringe accuracy +/- 5%

Figure 12: Modeling the Stent Graft with the Balloon

11.3.7.6 If desired, an angiogram may be performed following balloon modeling using the procedure described in Section 11.3.6.

11.3.7.7 If there is any focal area narrowing, use a PTA balloon (inflated diameter < graft diameter). If the area is still narrow after ballooning, place a stent graft extension. Do not leave any focal area untreated with significant narrowing or abrupt kinks of the connecting bar; this can lead to thrombosis, damage of the stent graft, or result in an incomplete distal seal.

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NOTE: Maintain vessel access until all Talent Abdominal Stent Graft components are placed.

11.3.8 Delivery System Removal

11.3.8.1 Ensure the balloon is deflated. Close the stopcock on the inflation port.

11.3.8.2 Withdraw the guidewire lumen into the introducer sheath (graft cover), re-establishing the smooth transition of the tip with the introducer sheath (graft cover). This can be verified by fluoroscopic examination of the introducer sheath (graft cover) marker band aligning with the radiopaque tip.

11.3.8.3 Tighten the tuohy borst Valve.

11.3.8.4 Gently remove the CoilTrac Delivery System. Do not use excessive force. Use fluoroscopy to ensure that the stent graft does not move during the withdrawal.

11.4 Implantation of the Contralateral Limb

11.4.1 Prepare the CoilTrac Delivery System

Prepare the CoilTrac Delivery System using the procedure described in Section 11.3.1.

11.4.2 Align the stent graft radiopaque markers with the patient’s anatomy

11.4.2.1 Visualize the radiopaque markers on the stent graft to identify positioning of the device within the sheath.

11.4.2.2 Turn the delivery system until the radiopaque markers, indicating the location of the connecting bar, are oriented on the outside of the most severe bend of the vessel.

11.4.2.3 Observe the position of the delivery system’s side port; use it as a reference in case the sheath turns during advancement in the aorta.

11.4.3 Introduce System

11.4.3.1 On the patient’s contralateral side, insert a guidewire through the short stub leg and the aortic neck portion of the previously placed bifurcated Talent Abdominal Stent Graft.

11.4.3.2 Advance the CoilTrac Delivery System over the guidewire and into the short stub leg of the deployed bifurcated stent graft. The connecting bar should always be oriented on the outside of the most severe bend of the vessel.

11.4.4 Confirm Position

To ensure proper docking of the contralateral limb, align the stub leg radiopaque marker with the proximal contralateral limb marker, ensuring at least 3cm of overlap between the components. The proximal spring of the iliac mating section should be inside and completely above the distal spring of the short leg. See Figure 13.

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Figure 13: Proper Docking of Contralateral Limb to Contralateral Leg

3 cm

CAUTION: Ensure through fluoroscopic visualization that the proximal section of the stent graft is not pulled down when deploying the contralateral limb in the short stub leg (contralateral side).

NOTE: Do not rotate the delivery system during deployment, as this may alter the orientation of the connecting bar.

11.4.5 Deploy Stent Graft

Hold the push rod stationary and begin to slowly draw back the introducer sheath (graft cover), verifying that the proximal spring is deploying in the correct position within the short leg. When deployed, the proximal-most spring of the iliac section should open inside of and just proximal to the distal-most spring of the short stub leg, "interconnecting" the two sections together. Complete deployment of the contralateral iliac segment.

11.4.6 Model Contralateral Limb

As necessary, the contralateral iliac limb can be modeled (see Figure 14) using the procedure outlined in Section 11.3.7.

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Figure 14: Talent Stent Graft System with the Modeling Balloon

11.4.7 Delivery System Removal

Remove the delivery system using the procedure described in Section 11.3.8.

11.4.8 Procedure Completion for Implantation of Stent Graft Main Body

At the completion of the procedure, perform angiography to assess the Talent Abdominal Stent Graft for proximal and distal endoleaks and to verify the position of the implanted stent graft in relation to the aneurysm and renal arteries. Endoleaks at the attachment or connection sites should be treated by using a modeling balloon, such as the Reliant Stent Graft Balloon Catheter, to model the stent graft against the vessel wall. Major endoleaks that cannot be corrected by re-ballooning may be treated by adding Talent Stent Graft Extension Cuff(s) to the previously placed stent graft.

CAUTION: Any endoleak left untreated during the implantation procedure must be carefully monitored after implantation.

If aortic and/or iliac extensions are needed, proceed to Section 11.5, otherwise continue to Section 11.4.9.

11.4.9 Close the Entry Site

11.4.9.1 Remove the introducer and the guidewire. Repair the entry site with standard closure techniques.

11.4.9.2 If, during placement of the Talent Abdominal Stent Graft, the arteries used for access to the aorta are injured, additional endovascular and/or surgical procedures to repair the injury will need to be performed. If vascular repair becomes necessary, follow appropriate institutional guidelines, including guidelines regarding continuation or termination of the overall stent graft procedure.

11.5 Aortic and Iliac Extensions

11.5.1 Usage of Radiopaque Markers to Ensure Minimum Overlap

In the event that an extension (iliac or aortic extension cuff) is used, the mating sections are joined by aligning specific radiopaque markers. These radiopaque markers indicate the MINIMUM recommended overlap. The radiopaque markers used for mating are offset 30mm from the end of the extension. The edges of the graft material and the connecting bar are indicated by the proximal and distal radiopaque markers. See Figure 15 and Figure 16 for orientation of iliac and aortic cuffs.

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11.5.2 Close the Entry Site

Figure 15: Orienting Iliac Extension Cuff

Align Figur8

Radiopaque Markers

Figure 16: Orienting the Aortic Extension Cuff

Align Figur8

Radiopaque Markers

11.5.2.1 Close the entry site using the procedure described in Section 11.4.9.

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12.0 IMAGING GUIDELINES AND POST-OPERATIVE FOLLOW-UP

A six month follow-up with CT Scan is recommended if an endoleak is reported at 1 month after the procedure

Imaging should be performed within 6 months before the procedure.

Duplex ultrasound may be used for those patients experiencing renal failure or who are otherwise unable to undergo

contrast enhanced CT scan. With ultrasound, non-contrast CT is still recommended.

If a Type I or III endoleak is present, prompt intervention and additional follow-up post-intervention is recommended. See

Section 12.6..

12.1 General

All patients should be advised that endovascular treatment requires life-long, regular follow-up to assess their health and the performance of their endovascular graft. Patients with specific clinical findings (e.g., endoleaks, enlarging aneurysms, or changes in the structure or position of the endovascular graft) should receive additional follow-up. Patients should be counseled on the importance of adhering to the follow-up schedule, both during the first year and at yearly intervals thereafter. Patients should be informed that regular and consistent follow-up is a critical part of ensuring the ongoing safety and effectiveness of endovascular treatment of AAAs.

Physicians should evaluate patients on an individual basis and prescribe follow-up relative to the needs and circumstances of each individual patient. The recommended imaging schedule is presented in Table 36. This schedule outlines the minimum requirement for patient follow-up and should be maintained even in the absence of clinical symptoms (e.g., pain, numbness, weakness). Patients with specific clinical findings (e.g., endoleaks, enlarging aneurysms, or changes in the structure or position of the stent graft) should receive follow-up at more frequent intervals.

Annual imaging follow-up may include abdominal radiographs and both contrast and non-contrast CT examinations and duplex ultrasounds. If renal complications or other factors preclude the use of image contrast media, abdominal radiographs, non-contrast CT, and duplex ultrasound should be used.

• The combination of contrast and non-contrast CT imaging provides information on aneurysm diameter change, endoleak, patency, tortuosity, progressive disease, fixation length and other morphological changes.

• The abdominal radiographs provide information on device integrity (separation between components and stent fracture).

• Duplex ultrasound imaging may provide information on aneurysm diameter change, endoleak, patency, tortuosity and progressive disease. In this circumstance, a non-contrast CT may be performed to use in conjunction with the ultrasound, since ultrasound may be less reliable. Ultrasound may be a less reliable and sensitive diagnostic method compared to CT.

Table 36 lists the minimum requirements for imaging follow-up for patients with the Talent Abdominal Stent Graft.

Table 36: Recommended Imaging Schedule for Endovascular Graft Patients

Interval Angiogram

[Contrast & Non-Contrast]

CT1

Abdominal

Radiographs

Pre-procedure X2

Procedural X

1 Month X

12 Months (annually thereafter) X

3,4

Ultimately, it is the physician’s responsibility, based on previous clinical results and the overall clinical picture, to determine the appropriate imaging schedule for a particular patient.

12.2 Contrast and Non-Contrast CT Recommendations

• Film sets should include all sequential images at the lowest possible slice thickness (<3mm). Do not perform large slice thickness (>3mm) and/or omit consecutive CT images/films sets, as this prevents precise anatomical and device comparisons over time.

• All images should include a scale for each film/image. Images should be arranged no smaller than 20:1 images on 14 inch X 17 inch sheets if film is used.

• Both non-contrast and contrast runs are required, with matching or corresponding table positions.

• Pre-contrast and contrast run slice thicknesses and intervals must match.

• DO NOT change patient orientation or re-landmark the patient between non-contrast and contrast runs.

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Non-contrast and contrast enhanced baseline and follow-up imaging are important for optimal patient surveillance. It is important to follow accepted imaging protocols during the CT exam. Table 37 lists examples of accepted imaging protocols.

Table 37: Accepted Imaging Protocols

IV contrast No Yes

Acceptable machines Spiral capable of > 40 seconds Spiral capable of > 40 seconds

Injection volume N/A 150cc

Injection rate N/A > 2.5cc/sec

Injection mode N/A Power

Bolus timing N/A Test bolus: SmartPrep, C.A.R.E. or equivalent

Coverage - start Diaphragm 1 cm superior to celiac axis

Coverage - finish Proximal femur Profunda femoris origin

Collimation <3mm <3mm

Reconstruction 2.5 mm throughout - soft algorithm 2.5mm throughout - soft algorithm

Axial DFOV

Post-injection runs None None

12.3 Abdominal Radiographs

The following views are suggested:

• Four films: supine-frontal (AP), cross-table lateral, 30 degree LPO and 30 degree RPO views centered on the umbilicus.

• Record the table-to-film distance and use the same distance at each subsequent examination.

Ensure the entire device is captured on each single image (formatted lengthwise).

If there is any concern about the device integrity (e.g., kinking, stent breaks, migration), it is recommended to use magnified views. The attending physician should evaluate films for device integrity (entire device length including components) using 2-4X magnification visual aid.

12.4 Ultrasound

Ultrasound imaging may be performed in place of contrast CT when patient factors preclude the use of image contrast media. In order to help support accurate evaluation, ultrasound images should be paired with noncontrast CT images. A complete aortic duplex should be videotaped and analyzed for maximum aneurysm diameter, endoleaks, stent patency and stenosis. Included on the videotape should be the following information as outlined below:

• Transverse and longitudinal imaging should be obtained from the level of the proximal aorta, including complete imagery from the mesenteric and renal arteries to the iliac bifurcations to determine if endoleaks are present. Utilize color flow and color power angiography (if available).

• Spectral analysis confirmation should be performed for any suspected endoleaks.

• Transverse and longitudinal imaging of the maximum aneurysm should be obtained.

12.5 MRI Safety and Compatibility

Non-clinical testing has demonstrated that the Talent Abdominal Stent Graft is MR Conditional. It can be scanned safely in both 1.5T & 3.0T MR systems under the following conditions:

1.5 Tesla Systems:

• Static magnetic field of 1.5 Tesla

• Spatial gradient field of 1000 Gauss/cm

• Maximum whole-body-averaged specific absorption rate (SAR) of 4W/kg for 15 minutes of scanning.

Based on non-clinical testing, the device was determined to produce a temperature rise of less than 1°C at a maximum whole body averaged specific absorption rate (SAR) of 4 W/kg for 15 minutes of MR scanning in a 64MHz whole body transmit coil, which corresponds to a static field of 1.5T. The maximum whole body averaged specific absorption rate (SAR) was derived by calculation and verified by calorimetry.

Non-Contrast Contrast

32cm 32cm

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3.0 Tesla Systems:

• Static magnetic field of 3.0 Tesla

• Spatial gradient field of 1000 Gauss/cm

• Maximum whole-body-averaged specific absorption rate (SAR) of 4W/kg for 15 minutes of scanning (or the

maximum SAR allowed by the MR System, whatever is less).

Based on non-clinical testing, the device was determined to produce a temperature rise of less than 1°C at a maximum whole body averaged specific absorption rate (SAR) of 4 W/kg for 15 minutes of MR scanning in a 3 Tesla Siemens TrioTIM (VB 13 Software) MR scanner. The maximum whole body averaged specific absorption rate (SAR) was derived by calculation and verified by calorimetry.

Image Artifact (1.5 Tesla & 3 Tesla Systems):

MR image quality may be compromised if the area of interest is in the same area or relatively close to the position of the device. Therefore, it may be necessary to optimize MR imaging parameters for the presence of this implant. The image artifact extends approximately 5 and 8mm from the device, both inside and outside the device lumen when scanned in non-clinical testing using the sequence: spin echo and gradient echo, respectively in a 3.0T Siemens TrioTIM (VB 13 Software) MR system with a whole body coil.

Patients with Talent Abdominal Stent grafts implanted in the abdominal aorta may safely undergo MRI for Normal Mode and First Level Controlled Operating Mode of the MR System, as defined in IEC Standard 606012-33.

12.6 Additional Surveillance and Treatment

Additional surveillance and possible treatment is recommended for:

• Aneurysms with endoleak

• Aneurysm enlargement, > 5mm of maximum diameter (regardless of endoleak status)

• Migration

• Inadequate seal length

• Fracture

Consideration for reintervention or conversion to open repair should include the attending physician's assessment of an individual patient's co-morbidities, life expectancy, and the patient's personal choices. Patients should be counseled that subsequent re-intervention, including the fact that catheter-based and open surgical conversion may become necessary following an endograft procedure.

13.0 DEVICE-RELATED ADVERSE EVENTS REPORTING

Any adverse event (clinical incident) involving the Talent Abdominal Stent Graft System should be reported to Medtronic Vascular immediately. To report an incident, call (800) 465-5533 (in the US).

14.0 PATIENT MATERIALS AND TRACKING INFORMATION

The Talent Abdominal Stent Graft System is packaged with additional specific information which includes:

• Temporary Patient Identification Card that includes both patient and stent graft information. Physicians should complete this card and instruct the patient to keep this card in their possession at all times. The patients should refer to this card anytime they visit additional health practitioners, particularly for any additional diagnostic procedures (e.g. MRI). This temporary identification card should only be discarded when permanent identification card is received.

• Device Tracking Form to be completed by the hospital staff and forwarded to Medtronic for the purposes of tracking all patients who received a Talent Abdominal Stent Graft (as required by Federal Regulation). The hospital’s submission of the device tracking form to Medtronic is also required for a patient to receive the permanent identification card.

Upon receipt of the device tracking form, Medtronic will mail the patient a permanent identification card. This card includes important information regarding the implanted stent graft. Patients should refer to this card anytime they visit health practitioners, particularly for any diagnostic procedures (e.g. MRI). Patients should carry this card with them at all times. In addition a patient information booklet (PIB) will be provided to the physicians during training and additional copies will be available upon request. The PIB will also be available online on the Medtronic website (www.medtronic.com endovascular repair therapy.

). This booklet provides patients with basic information on abdominal aortic aneurysms and

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15.0 CONFIGURATIONS AVAILABLE

Table 38: Bifurcated Stent Grafts with the CoilTrac Delivery System

(Fr.)

Bifurcated

(mm x mm)

36x20 36x18

34x20 34x18 34x16

32x20 32x18 32x16 32x14

30x20 30x18 30x16 30x14

28x20 28x18 28x16 28x14

Covered

Length

(mm)

155, 170

140, 155,

170

Proximal

Configuration

FreeFlo

Distal

Configuration

Closed Web

26x18

The delivery system working length is 45cm. The total length of the stent graft can be determined by adding approximately 15mm to the covered length shown above.

Table 39: Contralateral Limbs with the CoilTrac Delivery System

(Fr.)

The delivery system working length is 45cm. The total length of the stent graft can be determined by adding approximately 15mm to the covered length shown above.

26x16 26x14 26x12

24x14 24x12

22x14 22x12

Contralateral

Limb

(mm x mm)

14x24 14x22

14x20 14x18 14x16 14x14 14x12

14x10

14x8

140, 155 Bare Spring

Covered

Length

(mm)

75, 90,

105

Proximal

Configuration

Open Web Closed Web

Distal

Configuration

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Table 40: Iliac Extension Cuffs with CoilTrac Delivery System

(Fr.)

Iliac Extension

(mm x mm)

22x22 79

22x18 74

18x24 18x22

18x18 18x16 18x14 18x12

20x16 74

20x20 79

Covered

Length

(mm)

140

Proximal

Configuration

Distal

Configuration

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18x20 18x18 18x16

18x14 75

The delivery system working length is 45cm. The total length of the stent graft can be determined by adding approximately 15mm to the covered length shown above.

Table 41: Aortic Extension Cuffs with CoilTrac Delivery System

(Fr.)

The catheter working length is 45cm. The total length of the stent graft can be determined by adding approximately 30mm to the covered length shown above.

18x12

16x16

16x12 75

14x14 80

14x10 75

12x12 81

12x08 75

10x10 81

Aortic Extension

(mm x mm)

36x36 26 34x34 32x32 30x30 28x28 29 26x26 24x24 22x22

Covered

Length

(mm)

Open Web Closed Web

Proximal

Configuration

FreeFlo

Bare Spring

Distal

Configuration

Open Web

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16.0 EXPLANATION OF SYMBOLS

Explanation of symbols that may appear on product labeling.

Contents: One (1) TALENT One (1) set of patient tracking materials One (1) instructions for use reference

ABDOMINAL Stent Graft System with COILTRAC

Do not use if package is damaged

Non-pyrogenic

Peel here

Pull tab to open

Store at room temperature in a dark, dry place

MR Conditional

CAUTION: Federal (USA) law restricts this device for sale by or on order of a physician.

Sterilized using ethylene oxide

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MANUFACTURER:

MEDTRONIC, INC. 710 Medtronic Parkway NE Minneapolis, MN 55432-5604 U.S.A. Tel: (763) 514-4000 Fax: (763) 514-4879

www.medtronic.com

MANUFACTURED IN: MEDTRONIC VASCULAR 3576 Unocal Place Santa Rosa, CA 95403 U.S.A. Tel: (707) 525-0111 Fax: (707) 525-0114

U. S. CUSTOMER SERVICE / PRODUCT INQUIRIES

Tel: (800) 961-9055 Fax: (800) 929-2133

Protected by one or more of the following United States patents: 5,190,546; 5,591,195; 5,713,917; 6,287,315; 6,306,141; 6,102,938; & 6,344,052. Additional patents pending in the United States as well as other countries. Licensed under U.S. Patent 5,871,536.

Rev A