Medtronic TB2222C201CP Instructions for Use

TALENT® THORACIC STENT GRAFT

WITH THE CAPTIVIA DELIVERY SYSTEM

INSTRUCTIONS FOR USE

CAUTION: FEDERAL (USA) LAW LIMITS THIS DEVICE FOR SALE BY OR

ON ORDER OF A PHYSICIAN.

IMPORTANT!

• Do not attempt to use the Talent

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 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 system in accordance with hospital,
administrative and/or government policies. Do not resterilize.

• Caution: Federal (U.S.) Law restricts this device to sale by or on

the order of a physician.

®

Thoracic Stent Graft System

TABLE OF CONTENTS

1.0 INTRODUCTION ................................................................................................................ 5

2.0 DEVICE DESCRIPTION..................................................................................................... 5

2.1 TALENT THORACIC STENT GRAFT SYSTEM ........................................................................ 5

2.2 TALENT THORACIC STENT GRAFT...................................................................................... 5

2.2.1 PROXIMAL MAIN SECTION................................................................................. 6

2.2.2 DISTAL MAIN SECTION ....................................................................................... 7

2.2.3 PROXIMAL EXTENSION ...................................................................................... 7

2.2.4 DISTAL EXTENSION ............................................................................................ 8

2.3 CAPTIVIA DELIVERY SYSTEM............................................................................................. 9

3.0 INDICATIONS FOR USE ................................................................................................. 11

4.0 CONTRAINDICATIONS ................................................................................................... 11

5.0 WARNINGS AND PRECAUTIONS .................................................................................. 11

5.1 GENERAL ....................................................................................................................... 11

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

5.3 IMPLANT PROCEDURE ..................................................................................................... 12

5.4 MAGNETIC RESONANCE IMAGING (MRI)........................................................................... 13

6.0 POTENTIAL ADVERSE EVENTS .................................................................................... 14

6.1 ADVERSE EVENT REPORTING.......................................................................................... 14

7.0 SUMMARY OF PIVOTAL US CLINICAL STUDY ............................................................ 15

7.1 SUBJECT ACCOUNTABILITY AND FOLLOW-UP.................................................................... 16

7.2 DEMOGRAPHICS AND BASELINE MEDICAL HISTORY .......................................................... 17

7.3 BASELINE ANEURYSM DATA ............................................................................................ 19

7.4 DEVICES IMPLANTED....................................................................................................... 20

7.5 STUDY RESULTS............................................................................................................. 22

7.5.1 SAFETY............................................................................................................... 22

7.5.2 EFFECTIVENESS ............................................................................................... 32

7.5.3 SUPPLEMENTARY ACUTE PROCEDURAL DATA........................................... 35

7.6 VALOR TEST GROUP RESULTS BY LESION TYPE............................................................. 36

7.6.1 SUBJECT DEMOGRAPHICS AND LESION CHARACTERISTICS ................... 36

7.6.2 PRIMARY AND SECONDARY SAFETY AND EFFECTIVENESS ENDPOINT

ANALYSIS BY LESION TYPE............................................................................ 38

8.0 PATIENT SELECTION ..................................................................................................... 40

8.1 INDIVIDUALIZATION OF TREATMENT.................................................................................. 40

9.0 PATIENT COUNSELING INFORMATION ....................................................................... 40

10.0 HOW SUPPLIED .............................................................................................................. 40

10.1 STERILITY ...................................................................................................................... 40

10.2 CONTENTS ..................................................................................................................... 40

10.3 STORAGE....................................................................................................................... 40

11.0 CLINICAL USE INFORMATION....................................................................................... 41

11.1 RECOMMENDED SKILLS AND TRAINING ............................................................................ 41

11.1.1 PATIENT SELECTION ........................................................................................ 41

11.1.2 PHYSICIAN SKILLS AND EXPERIENCE ........................................................... 41

11.2 MATERIALS RECOMMENDED FOR DEVICE IMPLANTATION .................................................. 41

11.3 PRE-TREATMENT PLANNING AND SELECTION OF STENT GRAFT ........................................ 42

12.0 IMPLANTATION INSTRUCTIONS................................................................................... 44

12.1 PICTORIAL REFERENCES................................................................................................. 44

12.2 VASCULAR ACCESS ........................................................................................................ 44

12.3 INITIAL ANGIOGRAM ........................................................................................................ 44

12.4 DEVICE PREPARATION .................................................................................................... 44

12.5 HYDROPHILIC COATING ACTIVATION................................................................................ 45

12.6 INTRODUCING THE CAPTIVIA DELIVERY SYSTEM............................................................... 45

12.7 POSITIONING THE CAPTIVIA DELIVERY SYSTEM ................................................................ 46

12.8 CONFIRMING STENT GRAFT POSITION AND VERIFY MARKERS........................................... 46

12.9 DEPLOYING THE TALENT THORACIC STENT GRAFT........................................................... 47

12.10 DEPLOYING TIP CAPTURE MECHANISM (FREEFLO STENT GRAFT DELIVERY SYSTEM ONLY)51

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12.11 REMOVING THE DELIVERY SYSTEM.................................................................................. 52

12.12 ANCILLARY BALLOON CATHETER MODELING .................................................................... 54

12.13 IMPLANTING ADDITIONAL COMPONENT SECTIONS............................................................. 55

12.14 TROUBLESHOOTING ........................................................................................................ 56

12.14.1 HANDLE DISASSEMBLY TECHNIQUE FOR PARTIAL STENT GRAFT

DEPLOYMENT ................................................................................................... 56

12.14.2 ALTERNATIVE INSTRUCTION FOR DEPLOYING TIP CAPTURE MECHANISM

............................................................................................................................ 56

13.0 IMAGING GUIDELINES AND POST-OPERATIVE FOLLOW-UP ................................... 57

13.1 GENERAL ....................................................................................................................... 57

13.2 ANGIOGRAPHIC IMAGING ................................................................................................. 57

13.3 CTA/MRA IMAGES ......................................................................................................... 57

13.4 X-RAY ........................................................................................................................... 58

13.5 MRI INFORMATION.......................................................................................................... 58

13.6 ADDITIONAL SURVEILLANCE AND TREATMENT .................................................................. 59

14.0 DEVICE-RELATED ADVERSE EVENTS REPORTING .................................................. 59

15.0 PATIENT MATERIALS AND TRACKING INFORMATION .............................................. 59

16.0 EXPLANATION OF SYMBOLS ........................................................................................ 60

LIST OF FIGURES

Figure 1: Thoracic Stent Graft - Main Section ................................................................................ 6

Figure 2: Thoracic Stent Graft - Additional Distal Main Section ..................................................... 7

Figure 3: Thoracic Stent Graft - Proximal Extension ...................................................................... 7

Figure 4: Thoracic Stent Graft - Distal Extension ........................................................................... 8

Figure 5a: Captivia Delivery System (The FreeFlo Stent Graft Delivery System) ........................ 10

Figure 6: Covered Portion (Top of Fabric) Placement Zones ....................................................... 12

Figure 7- Kaplan-Meier Plot of Freedom from All Cause Mortality at 30 Days and 12 Months:

VALOR Test Group vs. Retrospective Open Surgery Group ........................................ 23

Figure 8 – Kaplan-Meier Plot of Freedom from Major Adverse Events at 30 Days: VALOR Test

Group vs. Retrospective Open Surgery ......................................................................... 27

Figure 9 – Kaplan-Meier Plot of Freedom from Serious Major Adverse Events: VALOR Test

Group Only..................................................................................................................... 29

Figure 10 – Kaplan-Meier Plot of Freedom from Aneurysm-Related Mortality at 12 Months:

VALOR Test Group vs. Retrospective Open Surgery Group ........................................ 31

Figure 11: Regions for Modular Overlaps ..................................................................................... 43

Figure 12: Tip Capture Release Handle in Locked Position ......................................................... 44

Figure 13: Introduce the Captivia Delivery System ....................................................................... 45

Figure 14a: Confirm Stent Graft Position (Proximal Main) ............................................................ 46

Figure 14b: Confirm Stent Graft Position (Distal Main) ................................................................. 46

Figure 15: Covered Portion (Top of Fabric) Placement Zones ..................................................... 48

Figure 16a: Deploying the Proximal End of the Stent Graft (FreeFlo) ......................................... 49

Figure 16b: Deploying the Proximal End of the Stent Graft (Open Web)..................................... 49

Figure 17a: Deploying the Remainder of the Stent Graft (FreeFlo) ............................................. 50

Figure 17b: Deploying the Remainder of the Stent Graft (Open Web) ........................................ 50

Figure 18: Unlocking the Tip Capture Release Handle ................................................................ 51

Figure 19: Deploying the Tip Capture Mechanism ....................................................................... 52

Figure 20: Delivery System Removal ........................................................................................... 53

Figure 21: Balloon Modeling of the Stent Graft ............................................................................ 54

LIST OF TABLES

Table 1 – Stent Graft Materials........................................................................................................ 5

Table 2 - Talent Thoracic Stent Graft Summary.............................................................................. 5

3

Table 3 - Subject and Imaging Accountability Table–VALOR Test Group Only ........................... 16

Table 4 - Subject Demographics: VALOR Test Group vs. Retrospective Open Surgery Group .. 17

Table 5 - Subject Anatomic Lesion Type: VALOR Test Group Only............................................. 17

Table 6 - Baseline Medical History: VALOR Test Group vs. Retrospective Open Surgery Group 18

Table 7 - Baseline Modified SVS Classification: VALOR Test Group Only .................................. 18

Table 8 - Baseline Maximum Aneurysm Diameters: VALOR Test Group vs. Retrospective Open

Surgery........................................................................................................................... 19

Table 9 - Baseline Vessel Dimensions (Core Lab Reported): VALOR Test Group Only.............. 19

Table 10- Number of Devices Implanted at Initial Procedure: VALOR Test Group Only.............. 20

Table 11: Number of Main Sections and Number of Extensions Implanted at Initial Procedure:

VALOR Test Group Only ............................................................................................... 20

Table 12 - VALOR Test Group: Talent Thoracic Stent Graft Devices Implanted .......................... 21

Table 13- VALOR Test Group: Distal Main Devices Implanted .................................................... 21

Table 14- All-Cause Mortality at 30 Days and 12 months: VALOR Test Group vs. Retrospective

Open Surgery................................................................................................................. 23

Table 15: Details of Kaplan-Meier Plot of Freedom from All Cause Mortality at 30 Days and 12

Months: VALOR Test Group vs. Retrospective Open Surgery Group........................... 24

Table 16 - Summary of Major Adverse Events for VALOR Test Group vs. Retrospective Open

Surgery Group (30 days) ............................................................................................... 25

Table 17- Freedom from Major Adverse Events (MAE) at 30 days: VALOR Test Group vs.

Retrospective Open Surgery Group .............................................................................. 26

Table 18: Details of Kaplan-Meier Plot of Freedom from Major Adverse Events at 30 Days:

VALOR Test Group vs. Retrospective Open Surgery ................................................... 27

Table 19 -Summary of Serious Major Adverse Events from VALOR Test Group Only ................ 28

Table 20- Freedom from Serious Major Adverse Events (MAE) at 30 days and 12-months:

VALOR Test Group Only ............................................................................................... 28

Table 21: Details of Kaplan-Meier Plot of Freedom from Serious Major Adverse Events: VALOR

Test Group Only............................................................................................................. 29

Table 22- Aneurysm-Related Mortality at 12 Months: VALOR Test Group vs. Retrospective Open

Surgery Group ............................................................................................................... 30

Table 23: Details of Kaplan-Meier Plot of Freedom from Aneurysm-Related Mortality at 12

Months: VALOR Test Group vs. Retrospective Open Surgery Group........................... 31

Table 24- Primary Effectiveness Endpoint: Successful Aneurysm Treatment: VALOR Test Group

....................................................................................................................................... 32

Table 25- Summary of Subjects with Primary Effectiveness Failure: VALOR Test Group ........... 32

Table 26 - Other Effectiveness Data: VALOR Test Group Only ................................................... 33

Table 27 - Supplementary Acute Procedural Data: VALOR Test Group vs. Retrospective Open

Surgery Group ............................................................................................................... 35

Table 28 - Subject Demographics by Lesion Type – VALOR Test Group Only............................ 36

Table 29 - Baseline Vessel Dimensions by Lesion Type: VALOR Test Group Only (Core Lab

Reported

Table 30: Baseline Vessel Shape by Lesion Type (Core Lab Reported1) – VALOR Test Group

Only................................................................................................................................ 38

Table 31: Primary Safety Endpoint: All Cause Mortality by Lesion Type – VALOR Test Group

Only................................................................................................................................ 38

Table 32: Primary Effectiveness Endpoint: Successful Aneurysm Treatment by Lesion Type –

VALOR Test Group Only ............................................................................................... 38

Table 33: Summary of Secondary Endpoints by Lesion Type – VALOR Test Group Only .......... 39

Table 34: Persistent Paraplegia/Paraparesis at 12 Months or last Follow-up by Lesion Type –

VALOR Test Group Only ............................................................................................... 39

Table 3 - Sizing Guidelines............................................................................................................ 42

Table 4 - Order of Deployment When Using Multiple Stent Graft Component Sections............... 43

Table 5 - Imaging Recommendations............................................................................................ 57

Table 6 - CTA Imaging Guidelines ................................................................................................58

1

)...................................................................................................................... 37

4

1.0 Introduction

The Talent® Thoracic Stent Graft System is intended for the endovascular repair of fusiform aneurysms and saccular
aneurysms/penetrating ulcers of the descending thoracic aorta. When placed within the target lesion, the stent graft
provides an alternative conduit for blood flow within the patient’s vasculature by excluding the lesion from blood flow and
pressure.

2.0

2.1 Talent Thoracic Stent Graft System

The Talent

• The Talent Thoracic Stent Graft

• The Captivia Delivery System

The Talent Thoracic Stent Graft is pre-loaded into the Captivia Delivery System. The loaded delivery system is inserted
endoluminally via the femoral or iliac artery and tracked through the patient’s vasculature to deliver the stent graft to the
target site.

2.2 Talent Thoracic Stent Graft

The Talent Thoracic Stent Graft is composed of a series of shaped, sinusoidal, self-expanding nitinol wire rings which act
as springs that are stacked in a tubular arrangement to form a self expanding nitinol structure. Proximal and distal springs
of the stent graft are connected by a full-length connecting bar. The self-expanding nitinol structure is covered by a mono­filament polyester woven graft. The graft material is sewn to the nitinol structure, which securely incorporates the springs
into the graft. Radiopaque markers, made out of platinum-iridium in shape of a figure eight (known as Figur8), are sewn
to the graft to help visualize and identify: the edge of the graft material, the location of the connecting bar, and the
minimum overlap required when multiple stent grafts are used. A support spring surrounding the proximal edge of the
graft material is also used in some configurations. Table 1 lists the materials comprising the stent graft.

The Talent Thoracic Stent Graft System is a modular device system that accommodates the use of multiple stent graft
sections. Depending on the patient’s anatomy, single or multiple stent grafts may be required to achieve sufficient
coverage and exclude the target lesion. Table 2 summarizes the features of various modular stent graft component
sections. Each component section is described in detail below.

Device Description

®

Thoracic Stent Graft System includes:

Table 1 – Stent Graft Materials

Stent Graft Component Material

Springs Nitinol wire (55% Nickel, balance Titanium with trace elements)
Connecting Bar Nitinol wire (55% Nickel, balance Titanium with trace elements)
Support Spring (FreeFlo™ only) Nitinol wire (55% Nickel, balance Titanium with trace elements)
Stent Fabric High-density woven mono-filament polyester
Sutures Braided polyester suture
Radiopaque Markers Figur8 Platinum Iridium wire

Component

Proximal
Main Section

Distal Main
Section
Proximal
Extension
Distal
Extension

Table 2 - Talent Thoracic Stent Graft Summary

Proximal End

Configuration

FreeFlo (>22mm)
Bare Spring (22mm)

Open Web Closed Web 130mm 110-114mm 26mm – 46mm Tapered Tube

FreeFlo (Bare Spring
with Support Spring)

Open Web Bare Spring 80-90mm 46-54mm 26mm – 46mm Straight Tube

Distal End

Configuration

Closed Web

Open Web 80-90mm 46-54mm 26mm – 46mm Straight Tube

Total

Length

130mm 112-116mm
175mm 157-161mm
215mm 197-201mm

Covered

Length

Available

Diameters

22mm – 46mm Straight Tube

Straight or

Tapered

Tube

5

2.2.1 Proximal Main Section

The proximal main section has an uncovered nitinol spring as the proximal end configuration, which allows for trans­vessel flow. Proximal main stent grafts with a proximal diameter greater than 22mm have a mini-support spring to aid in
sealing. The proximal end configuration in which an uncovered nitinol spring and mini-support spring are present is called
the ‘FreeFlo’ configuration. The proximal end configuration in which an uncovered nitinol spring is present without a mini­support spring is called a ‘Bare Spring’ configuration. The distal end of the stent graft has a Closed Web configuration.
The two proximal markers and two distal markers indicate the ends of the covered portion of the stent graft. The middle
marker indicates the rotational position of the connecting bar. See Figure 1.

Figure 1: Thoracic Stent Graft - Main Section

[GRAPHICAL REPRESENTATION ONLY. MAY APPEAR DIFFERENTLY UNDER FLUOROSCOPY]

6

2.2.2 Distal Main Section

Distal main sections are used to increase the length of coverage of the treated vessel when the proximal main section is
inadequate in length to exclude the aneurysm. The proximal end of the distal main section utilizes a configuration in
which the outline of the most proximal spring is covered with fabric leaving a “tulip” effect, called Open Web. The distal
end of the distal main section is a Closed Web configuration. Two alignment markers are used to indicate the 30mm
minimum overlap with the mating graft. The two distal markers indicate the bottom edge of the covered portion of the
stent graft. The middle marker indicates the rotational position of the connecting bar. See Figure 2.

Figure 2: Thoracic Stent Graft - Additional Distal Main Section

MIDDLE MARKER

[GRAPHICAL REPRESENTATION ONLY. MAY APPEAR DIFFERENTLY UNDER FLUOROSCOPY]

2.2.3 Proximal Extension

Proximal extensions are intended to be used when the proximal end of the stent graft requires extension to fully exclude
the target lesion, or to treat proximal Type I endoleaks. The proximal extension is deployed within the proximal end of the
proximal main section. The proximal end of the proximal extension section has a FreeFlo configuration, which allows for
trans-vessel flow. The distal end of the proximal extension section has an Open Web configuration. The two proximal
markers indicate the top edge of the covered stent graft. The single alignment marker is used to indicate the 30mm
minimum overlap with the mating graft, as well as the rotational location of the connecting bar. See Figure 3.

Figure 3: Thoracic Stent Graft - Proximal Extension

FREEFLO

MINI SUPPORT SPRING

[GRAPHICAL REPRESENTATION ONLY. MAY APPEAR DIFFERENTLY UNDER FLUOROSCOPY]

7

2.2.4 Distal Extension

Distal extensions are intended to be used when the distal end of the stent graft requires extension to fully exclude the
target lesion, or to treat distal Type I endoleaks. The distal extension is deployed in the distal end of the proximal main or
distal main section and extends distally. The proximal end has an Open Web configuration. The distal end has a bare
spring extending beyond the edge of the fabric, which allows for trans-vessel flow. The single “alignment marker”
indicates the 30mm minimum overlap with the mating graft, as well as the rotational position of the connecting bar. The
two distal markers indicate the bottom edge of the covered portion of the stent graft. See Figure 4.

Figure 4: Thoracic Stent Graft - Distal Extension

[GRAPHICAL REPRESENTATION ONLY. MAY APPEAR DIFFERENTLY UNDER FLUOROSCOPY]

8

2.3 Captivia Delivery System

The Captivia Delivery System consists of a single use, disposable catheter with an integrated handle to provide the user
with controlled deployment. The Captivia Delivery System is the generic name for two particular delivery system
configurations:

• The FreeFlo Stent Graft Delivery System – Used with the FreeFlo Straight Proximal Main and Free Flow
Straight Proximal Extension Configuration stent grafts. Features a tip capture mechanism in which the
stent graft is deployed in two stages – (1) deployment of the stent graft with the bare stent of the FreeFlo
configuration still constrained, and (2) release of the bare stent. This particular delivery system allows for
a more controlled deployment of the stent graft in the thoracic aortic environment.

• The Open Web Stent Graft Delivery System – Used with the Open Web Tapered Distal Main and Open
Web Straight Distal Extension Configuration stent grafts. Features a one-stage deployment of the stent
graft.

The Captivia Delivery System is a multi-lumen device, with each lumen serving a different function:

1) The inner member provides a lumen to allow the system to track over a 0.035" (0.89 mm) guidewire.

2) The tip capture tube (for the FreeFlo Stent Graft Delivery System only) provides a lumen to actuate the tip
capture mechanism.

3) The flexible stent stop provides a lumen to aid in tracking the system through tortuous anatomy and maintains
stent graft position during deployment.

4) The graft cover, with stainless steel braid, provides a lumen to contain the stent graft during tracking and from
which the stent graft is released during deployment.

A flexible tapered tip is attached to the end of the inner member and provides a smooth transition from the guidewire to
the outer graft cover. The tapered tip and graft cover are coated with a lubricious hydrophilic coating to facilitate vessel
access and tracking through tortuous anatomy. A distal radiopaque marker indicates the graft cover edge under
fluoroscopy. A hemostasis valve at the proximal end of the delivery system minimizes blood loss and leaking during the
procedure. The stent graft is deployed by rotating or retracting the integrated slider/handle. The tip capture release
handle at the rear of the delivery system is unlocked and retracted to release the bare stent of the FreeFlo configuration,
thereby completing deployment of the stent graft (the tip capture feature is only available on the FreeFlo Stent Graft
Delivery System).

NOTE: THE CAPTIVIA DELIVERY SYSTEM WILL ACCOMMODATE ONLY A 0.035” (0.89 MM) GUIDEWIRE.

9

Figure 5a: Captivia Delivery System (The FreeFlo Stent Graft Delivery System)

Figure 5b: Captivia Delivery System

(The Open Web Stent Graft Delivery System)

1. Luer Connector 9. Stent Stop Insert

2. Sideport Extension 10. Tip Capture Mechanism

3. Screw Gear 11. RO Marker Band

4. Slider / Handle 12. Tapered Tip

5. Trigger 13. Back End Lock

6. Front Grip 14. Tip Capture Release Handle

7. Strain Relief 15. Clamping Ring

8. Graft Cover (Introducer
Sheath)

10

3.0 Indications for Use

The Talent Thoracic Stent Graft System is intended for the endovascular repair of fusiform aneurysms and saccular
aneurysms/penetrating ulcers of the descending thoracic aorta in patients having appropriate anatomy, including:

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

• non-aneurysmal aortic diameter in the range of 18 – 42mm; and

• non-aneurysmal aortic proximal and distal neck lengths ≥ 20mm

4.0 Contraindications

The Talent Thoracic 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).

5.0

5.1 General

5.2 Patient Selection, Treatment and Follow-Up

Warnings and Precautions

• 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 Thoracic Stent Graft System should only be used by physicians and teams trained in vascular
interventional techniques, including training in the use of this device. Specific training expectations are
described in Section 11.1.

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

• Do not attempt to use the Talent Thoracic Stent Graft with the Captivia Delivery System in patients unable to
undergo the necessary preoperative and postoperative imaging and implantation studies as described in
Section 13.0.

• The Talent Thoracic 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 Thoracic 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

11.3. Key anatomic elements that may affect successful exclusion of the aneurysm include severe neck
angulation, short aortic neck(s) and significant thrombus and/or calcium at the arterial implantation sites. In the
presence of anatomical limitations, a longer neck length may be required to obtain adequate sealing and
fixation.

• The use of this device requires administration of radiographic agents. Patients with preexisting renal
insufficiency may have an increased risk of renal failure postoperatively.

• The safety and effectiveness of this device in the treatment of dissections have not been established. In the
first 10 years of clinical experience (OUS-commercial and US-investigational), there were 39 reported events of
retrograde dissection in patients. Of the 39 reported events, 33 patients had a pre-existing aortic dissection.

• Inappropriate patient selection may contribute to poor device performance.

• The safety and effectiveness of the Talent Thoracic Stent Graft has not been evaluated in the following patient

situations and/or populations in which:

 Planned placement of the COVERED (top edge of fabric) portion of the stent graft requires implant to

occur in zones 0 or 1 (See Figure 6).

11

Figure 6: Covered Portion (Top of Fabric) Placement Zones

 The patient’s access vessel (as determined by treating physician) precludes safe insertion of the delivery

system.

NOTE: ILIAC CONDUITS MAY BE USED TO ENSURE THE SAFE INSERTION OF THE DELIVERY SYSTEM.

 Patient requires a planned aortic conduit.
 Patient has a thoracic aneurysm with a contained rupture.
 Patient has a connective tissue disease (e.g., Marfan’s syndrome, medial degeneration).
 Patient has received a previous stent and/or stent graft or previous surgical repair in the descending

thoracic aortic area.

 Patient requires treatment of an infra-renal aneurysm at the time of implant.
 Patient has had previous surgical or endovascular treatment of an infra-renal aortic aneurysm.
 Patient has a history of bleeding diathesis, coagulopathy, or refuses blood transfusions.
 Patient has had a recent (within 3 months) Cerebral Vascular Accident (CVA).
 The patient has a known hypersensitivity or contraindication to anticoagulants or contrast media, which is

not amenable to pre-treatment.

 The presence of significant and/or circumferential aortic mural thrombus at either the proximal or distal

attachment sites that would compromise fixation and seal of the implanted stent graft.

 Pregnant females.
 Patients less than 18 years old.

• The long-term safety and effectiveness of this implant have not been established. All patients with
endovascular aneurysm repair must undergo periodic imaging to evaluate the stent graft and aneurysm size.
Significant aneurysm enlargement (>5 mm), the appearance of a new endoleak, or migration resulting in an
inadequate seal zone should prompt further investigation and may indicate the need for additional intervention
or surgical conversion.

• 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.

5.3 Implant Procedure

• Oversizing of the stent graft to vessel more than 10% may be unsafe, especially in the presence of dissecting
tissue or intramural hematoma.

• A seal zone less than 20mm could increase the risk of endoleak or migration of the stent graft. Migration may
also be caused by deployment of the proximal spring into a thrombus-filled or severely angled vessel wall.

• Manipulation of wires, balloons, catheters, and endografts in the thoracic aorta may lead to vascular trauma
including aortic dissection and embolization.

• Wrinkling of graft material may promote thrombus formation. Inflate a conformable balloon within the deployed
stent graft lumen to reduce wrinkling of the graft material.

TM

• Use the Reliant
Device. Do not attempt to use the Reliant Stent Graft Balloon Catheter before completely reading and
understanding the information supplied with the Reliant Device.

• Do not use the Reliant Stent Graft Balloon Catheter in patients with history of thoracic dissection disease. Do
not over-inflate the Reliant Stent Graft balloon within or outside of the graft material.

• When expanding a vascular prosthesis using the Reliant Balloon, 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 prosthesis.

Stent Graft Balloon Catheter according to the instructions for use supplied with the Reliant

12

• Failure to align the connecting bar with the outer bend of the target vessel may increase the likelihood of
endoleaks post implantation.

• During general handling of the Captivia Delivery System, avoid bending or kinking the graft cover because it
may cause the Talent Thoracic Stent Graft to prematurely and improperly deploy.

• It is not recommended to position the device higher in the presence of excessive calcification or thrombus, due
to the increased risk of dislodging material during distal repositioning of the Stent Graft.

• The proximal edge of the covered portion of the Stent Graft should not be placed beyond the origin of the left
common carotid artery (i.e., Zone 0 or Zone 1, See Figure 6).

• Ensure that the proximal and distal springs are placed in an adequate landing zone comprised of healthy tissue.
Healthy tissue is defined as tissue without evidence of circumferential thrombus, intramural hematoma,
dissection, ulceration, and/or aneurysmal involvement. Failure to do so may result in inadequate exclusion or
vessel damage, including perforation.

• The retrieval of the tip must be carefully monitored with fluoroscopic guidance to ensure that the tip does not
cause the Talent Thoracic Stent Graft to be inadvertently pulled down.

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

NOTE: THE RELIANT STENT GRAFT BALLOON CATHETER IS RECOMMENDED FOR USE WITH THE TALENT

THORACIC STENT GRAFT. DATA IS NOT AVAILABLE FOR USE WITH OTHER BALLOONS FOR
REMODELING STENT GRAFTS.

5.4 Magnetic Resonance Imaging (MRI)

MRI may be used on the graft only under specific conditions. See Section 13.5: MRI INFORMATION for details.

13

6.0 Potential Adverse Events

Adverse events associated with use of the Talent Thoracic Stent Graft System include, but are not limited to the following:

• Amputation

• Aneurysm Enlargement

• Balloon rupture

• Breakage of the metal portion of the device

• Cardiac Failure/Infarction

• Change in mental status

• Conversion to open surgery

• Death

• Deployment difficulties

• Edema

• Embolization

• Endoleak

• Erectile Dysfunction

• Erosion with fistula or pseudoaneurysm

• Failure to deploy

• Gastrointestinal complications, including: adynamic ileus, bowel (ileus, transient ischemic, infarction, necrosis)

• Graft twisting and/or kinking

• Hemorrhage/Bleeding

• Inaccurate placement

• Infection and fever

• Insertion and removal difficulties

• Intercostal pain

• Neurological complications, including: spinal cord ischemia with paraplegia, paraparesis and/or paresthesia,

Cerebral Vascular Accidents (CVA), Transient Ischemic Attacks (TIA), neuropathy, and blindness

• Prosthetic thrombosis

• Pulmonary complications

• Renal failure

• Rupture of graft material

• Ruptured vessel/aneurysm sac enlargement

• Stent graft migration

• Vascular complications including: thrombosis, thromboembolism, occlusion (arterial and venous), vessel

dissection

• Wound healing complications

1

or perforation, collateral vessel occlusion, vascular ischemia, tissue necrosis, amputation

6.1 Adverse Event Reporting

Any adverse event (clinical incident) involving the Talent Thoracic Stent Graft System should be reported to Medtronic
immediately. To report an incident, call [phone] (in the US).

1

Aortic dissection is an infrequent but recognized risk of endovascular repair. In the first 10 years of clinical experience
(OUS-commercial and US-investigational), there were 39 reported events of retrograde dissection in patients. Of the 39
reported events, 33 patients had a pre-existing aortic dissection

14

7.0 Summary of Pivotal US Clinical Study

The VALOR Pivotal Study (VALOR Test Group) was a multi-center, non-randomized clinical study conducted within the
United States in order to evaluate the safety and effectiveness of the Talent Thoracic Stent Graft System when used in
the treatment of subjects with descending thoracic aortic aneurysms (fusiform aneurysms and saccular
aneurysms/penetrating ulcers). For the VALOR Test Group, 38 sites enrolled a total of 195 subjects. The primary safety
endpoint was All-Cause Mortality at one year. The All-Cause Mortality rate of TAA repair with the Talent Thoracic Stent
Graft was to be compared to the literature All-Cause Mortality rate for open surgical TAA repair, within one year of the
initial procedure. The primary effectiveness endpoint, Successful Aneurysm Treatment
80%, derived from a control population from the Feasibility studies totaling 21 subjects with 1 year of follow-up, all of
whom met the protocol definition of Successful Aneurysm Treatment.

In the VALOR Test Group, analysis of the primary endpoints used follow-up visits at 1, 6 and 12 months after the implant
procedure and annually for a total of 5 years from the date of the initial implant. Clinical sites sent CT/MR and chest X-ray
(CXR) images to an independent Core Laboratory to provide an assessment of patient data through one year post
implantation. All major adverse events (MAEs) were adjudicated by an independent Clinical Events Committee (CEC) for
device and procedure relatedness.

Original Literature Control

The original literature control compared the All-Cause Mortality rate of TAA repair of the Talent Thoracic Stent Graft with
the literature All-Cause Mortality rate for open surgical TAA repair, within one year of the initial procedure. Based on the
adequacy of information regarding disease etiology, length of follow-up information and definition of events, three articles
were chosen, from which 608 subjects had atherosclerotic lesions that accurately fit the VALOR Test Group’s intended
patient population of descending thoracic aortic aneurysms. Of the 608 patients, the number of patients surviving at 12
months was estimated from the 12 month rates given in the Kaplan-Meier curves included in each article. Using this
method, 181 patients were estimated to have died within one year, establishing an All-Cause Mortality rate of 29.8%. The
result of Primary Safety Endpoint comparison between the VALOR Test Group and the Original Literature Control Group
is included in Section 7.5.1 (page 22) below.

Retrospective Open Surgery Control

After the original VALOR Trial was conducted, additional retrospective open surgical data was gathered from selected
surgical centers to serve as a comparator for Acute Procedural Outcomes and Acute Adverse Events, as well as to further
compare early and 12-Month Mortality and Aneurysm-Related Mortality. This retrospective surgical control group included
189 subjects from 3 centers who matched selected inclusion/exclusion criteria of the VALOR study. The VALOR Test
and Retrospective Open Surgery Groups included surgical candidates diagnosed with a thoracic aortic aneurysm of
degenerative etiology. The VALOR Test Group candidates were of low to moderate risk (SVS 0, 1, and 2). The
Demographics and Baseline Medical History comparison between the VALOR Test Group and Retrospective Open
Surgery Group is included in Section 7.2. Baseline Aneurysm Data comparison is included in section 7.3. Safety
information is compared in section 7.5.1 (page 21 onwards) and effectiveness data and procedural result comparison is
provided in section 7.5.2 and 7.5.3.

2

, was compared to a fixed rate of

2

Successful Aneurysm Treatment was a composite endpoint defined as no aneurysm growth greater than 5 mm at the 12
month follow-up visit when compared to the one (1) month follow-up visit (after the initial Talent Thoracic Stent Graft
implant) AND absence of a Type I endoleak for which a secondary procedure was performed before, at or as a result of
the 12 month follow-up visit.

15

7.1 Subject Accountability and Follow-up

For the VALOR Test Group, 38 sites enrolled a total of 195 subjects. One (1) subject had technical failure and did not
receive a stent graft and therefore did not have any imaging follow-up. Four (4) subjects died and one (1) withdrew from
the study before the 1-month visit.

189 subjects were eligible for clinical and imaging follow-up at 1 month follow-up interval. Of these 189 subjects, 80.4%
(152/189) had a clinical follow-up. Please note; three (3) additional patients who were not eligible for clinical follow-up had
imaging follow-up within the expanded time windows (as footnoted within the Table 3 below).

At the 6 month follow-up interval, 173 subjects were eligible for clinical and imaging follow-up. Of these, 74.0% (128/173)
had clinical follow-up and 73.8 % (127/173) had imaging follow-up. CT imaging was performed on 68.2% (118/173)
subjects.

At the 12 month follow-up interval, 157 subjects were eligible for clinical and imaging follow-up. Of these 71.3% (112/157)
had clinical follow-up and 90.4% (142/157) had imaging follow-up. CT imaging was performed on 82.8% (130/157)
patients.

Detailed subject follow-up and accountability for 1, 6, and 12 months is provided in Table 3.

Table 3 - Subject and Imaging Accountability Table–VALOR Test Group Only

Patients with

Patient follow-up

2

imaging

performed at time

interval

(Core Lab)

3

3

3

Patients with adequate

imaging to assess the

3

parameter

3

Patient events occurring before next

4

3

visit

2

Eligible

Clinical

Treatment / Follow-up

Interval

Originally Enrolled 195 1

Events after implant but before

1 Month visit

1 Month 189 152 192 184 189 174 182 161

Events after 1 Month visit but

before 6 Month visit

6 Month 173 128 127 118 114 117 112 117 93

Events after 6 Month visit but

before 12 Month visit

12 Month 157 112 142 130 125 129 123 129 97

0 4 1 0

0 14 2 0

1 13 1 1

Imaging

Follow-up

Follow-up

CT Imaging

Aneurysm

KUB Imaging

Endoleak

size increase

Integrity

Migration

Failure

Technical

Conversion to

Death

Surgery

Withdrawal

1 Data analysis sample size varies for each of the time points above and in following tables. This variability is due to patient availability for follow-

up, as well as, quantity and quality of images available from specific time points 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.

2 Protocol-defined time windows were used for clinical follow-up and patient events

1-month : 16days to 44 days
6 month: 153 days to 213 days
12-month: 335 days to 395 days

3 Expanded time windows were used for Imaging follow-up and assessment of imaging-dependant parameters

1-month: 0 days to 122 days
6 month: 153 days to 213 days
12-month: 335 days to 480 days for CT, Endoleak and Aneurysm size increase
335 days to 760days for X-ray and Integrity

4 Number of subjects evaluable for migration assessment were based on CT performed in windows and Slice interval and thickness <5mm for

10mm evaluation

Lost to

Follow-up

16

7.2 Demographics and Baseline Medical History

Table 4 to Table 7; provide the demographics of the VALOR Test Group and Retrospective Open Surgery Group subjects.

Table 4 - Subject Demographics: VALOR Test Group vs. Retrospective Open Surgery Group

VALOR Test Group

AGE

Total Population

Mean ± SD (years) 70.2 ± 11.1 69.6 ± 9.1 0.528

Mean ± SD (years) 69.3 ± 11.7 69.9 ± 8.5 0.680

Mean ± SD (years) 71.6 ± 10.1 69.3 ± 9.8 0.130

Gender

Ethnicity

White, non-Hispanic 83.1% (162) 93.7% (177)
Black- non-Hispanic 12.8% (25) 5.8% (11)

Hispanic (White or

Asian/Pacific Islander 1.0% (2) 0% (0)

Native American 0% (0) 0% (0)

1

One subject had Ethnicity specified as “None given”

N 195 189

Median 73.0 71.0

Min-Max 27 - 86 27 - 85

Male

N 115 99

Median 72.0 71.0

Min-Max 27 - 85 40 - 84

Female

N 80 90

Median 74.0 71.0

Min-Max 38 - 86 27 - 85

Males 59.0% (115) 52.4% (99)

Females 41.0% (80) 47.6% (90)

Black)

Other 0.5% (1) 1 0% (0)

2.6% (5) 0.5% (1)

Retrospective Open

Surgery

p-value

0.218

0.007

Table 5 - Subject Anatomic Lesion Type: VALOR Test Group Only

Thoracic Lesion

Fusiform 112 57.4

Saccular/Penetrating Ulcer 70 35.9

Both 13 6.7

The Retrospective Open Surgery Group did not provide patient level data for Anatomic Lesion Type treated.

Note;

N %

17

Table 6 - Baseline Medical History: VALOR Test Group vs. Retrospective Open Surgery Group

Body System / Condition

VALOR Test Group

% (m/n)

1

Retrospective Open

Surgery

1

% (m/n)

p-value

Cardiovascular

Angina 14.4% (28/195) 22.8% (26/114) 0.064

Arrhythmias 26.7% (52/195) 20.3% (37/182) 0.182

Carotid artery disease 5.6% (11/195) Not Available N/A

Congestive heart failure (CHF) 8.7% (17/195) 11.2% (21/187) 0.495

Coronary artery bypass grafting (CABG) 10.3% (20/195) 13.3% (25/188) 0.428

Coronary artery disease (CAD) 40.5% (79/195) 49.2% (91/185) 0.099

Hypertension 87.2% (170/195) 88.8% (166/187) 0.641

Myocardial infarction (MI) 13.8% (27/195) 20.9% (39/187) 0.079

Percutaneous coronary intervention (PCI) 5.6% (11/195) Not Available N/A

Peripheral vascular disease (PVD) 16.4% (32/195) 37.4% (70/187) <0.001

Symptomatic thoracic aortic aneurysm 26.2% (51/195) Not Available N/A

Abdominal Aortic Aneurysm (AAA) 19.0% (37/195) 37.0% (70/189) <0.001

Abdominal Aortic Aneurysm Repair 2.1% (4/195) 27.5% (52/189) <0.001

Gastrointestinal conditions 53.8% (105/195) Not Available N/A

Renal insufficiency 17.4% (34/195) 16.0% (30/187) 0.784

Musculoskeletal conditions 53.8% (105/195) Not Available N/A

Neurological

Cerebral vascular accident (CVA) 9.7% (19/195) 13.4% (25/186) 0.267

Paraplegia 1.0% (2/195) 0.5% (1/186) 1.000

Paraparesis 0.5% (1/195) Not Available N/A

Transient ischemic attack (TIA) 7.7% (15/195) Not Available N/A

Pulmonary

Chronic obstructive pulmonary disease (COPD) 36.9% (72/195) 42.6% (80/188) 0.296

Tobacco use 76.9% (150/195) 75.9% (142/187) 0.904

Other abnormal body systems

Hyperlipidemia 43.6% (85/195) Not Available N/A

Diabetes 15.9% (31/195) 8.6% (16/187) 0.030

Bleeding disorders 2.6% (5/195) Not Available N/A

1m = number in category, n = number of known values

Table 7 - Baseline Modified SVS Classification: VALOR Test Group Only

Modified SVS

n

195 4.1% (8) 21.0% (41) 72.8% (142) 2.1% (4)

SVS 0
% (m)

18

SVS 1
% (m)

SVS 2
% (m)

SVS 3
% (m)

7.3 Baseline Aneurysm Data

Table 8 lists the initial aneurysm diameter sizes treated.

Table 8 - Baseline Maximum Aneurysm Diameters: VALOR Test Group vs. Retrospective Open Surgery

VALOR Test Group

Aneurysm

Diameter (mm)

Site-Reported

% (m / n)

1

Core Lab
Reported

% (m / n)

2

Retrospective
Open Surgery

%(m/n)

10-17 0% (0/188) 0% (0/187) 0% (0/189)

18-29 0% (0/188) 0.5% (1/187) 0% (0/189)

30-39 4.3% (8/188) 7.5% (14/187) 0% (0/189)

40-49 10.6% (20/188) 20.3% (38/187) 0.5% (1/189)

50-59 34.6% (65/188) 34.8% (65/187) 13.8% (26/189)

60-69 33.5% (63/188) 24.6% (46/187) 40.7% (77/189)

70-79 12.2% (23/188) 10.2% (19/187) 24.3% (46/189)

80-89 3.2% (6/188) 2.1% (4/187) 16.9% (32/189)

90-99 1.1% (2/188) 0% (0/187) 0.5% (1/189)

100-109 0.5% (1/188) 0% (0/187) 1.6% (3/189)

110-119 0% (0/188) 0% (0/187) 0.5% (1/189)

120+ 0% (0/188) 0% (0/187) 1.1% (2/189)

1 Denominator is 188 subjects with site reported data.
2 Denominator is 187 subjects with evaluable scans.
3 This p-value represents a Monte Carlo estimate of the p-value for the exact Mantel-Haenszel Chi-

Square test for trend, based on 100,000 Monte Carlo repetitions.

p-value

Site-Reported

VALOR vs.

Retrospective

Open Surgery

<0.001

3

Table 9 - Baseline Vessel Dimensions (Core Lab Reported): VALOR Test Group Only

Vessel Dimensions (mm) n

1

Mean ± SD Median Min Max

Proximal neck diameter 187 31.2 ± 4.9 31.5 18.5 43.5

Aneurysm diameter 187 55.5 ± 11.6 56.0 26.2 88.8

Distal neck diameter 184 29.7 ± 5.0 29.5 17.0 42.5

Proximal neck length 187 80.0 ± 52.1 77.9 10.0 234.0

Aneurysm length 180 121.4 ± 72.7 107.7 8.0 297.5

Distal neck length 184 90.0 ± 62.9 73.5 9.0 255.0

Right external iliac minimum diameter 122 6.5 ± 1.5 6.5 2.9 11.0

Left external iliac minimum diameter 124 6.6 ± 1.5 6.5 3.3 10.9

1 Denominators are n specified from readable scans.

19

7.4 Devices Implanted

Table 10 provides details on the number of devices implanted per subject for the VALOR Test Group.

Table 10- Number of Devices Implanted at Initial Procedure: VALOR Test Group Only

Devices Implanted

Number per subject % (m)1

0

1 19.5% (38)

2 28.7% (56)

3 24.6% (48)

4 17.4% (34)

5 7.2% (14)

6 1.5% (3)

7+ 0.5% (1)

1

m= number of subjects implanted & percentages based on total number of

enrolled subjects (N=195)

Table 11 cross-tabulates the 194 subjects in the VALOR Test Group, who had Talent Stent Grafts implanted by the
number of main sections and the number of extensions. For example, 38 subjects had a single main section implanted
and no extensions, and 5 subjects had one main section and one extension. Similarly, 51 subjects had two main sections
and no extensions and 6 had two main sections and one extension.

0.5% (1)

Table 11: Number of Main Sections and Number of Extensions Implanted at Initial Procedure: VALOR Test Group

1

m (%)

0 1 2 Total

1

2

Number of

Main

Sections

1 m= number of subjects with tabulated number of main sections and extensions. Percentages based on total number of

implanted subjects (N=194)

3

4

5

6

Total

38 (19.59%) 5 (2.58%) 1 (0.52%) 44 (22.68%)

51 (26.29%) 6 (3.09%) 5 (2.58%) 62 (31.96%)

41 (21.13%) 11 (5.67%) 2 (1.03%) 54 (27.84%)

18 (9.28%) 6 (3.09%) 0 (0.00%) 24 (12.37%)

6 (3.09%) 1 (0.52%) 0 (0.00%) 7 (3.61%)

2 (1.03%) 1 (0.52%) 0 (0.00%) 3 (1.55%)

156 (80.41%) 30 (15.46%) 8 (4.12%) 194 (100.00%)

Only

Number of Extensions

20