Page 1
Proximal Cerebral Protection Device
INSTRUCTIONS FOR USE
Caution: Federal (USA) law restricts this product for sale by or on the order of a physician.
0110090-4 Manufacturer
Medtronic, Inc., Minneapolis, MN
Page 2
INSTRUCTIONS FOR USE
x3
10
1
9
8
7
6
6
5
4
3
2
x1
13
x1
12
x2
11 1
x1
Figure 1.
1. Y-piece with hemostatic valve and flexible extension tubing
(17 cm length)
2. Exit port of the working channel
3. Hollow mandrel, 0.035" guidewire compatible, to insert
inside the working channel during Mo.Ma Ultra introduction
4. Shaft with 9F outer diameter
5. 3-way stopcock and flexible extension tubing (1)
6. Balloon inflation/deflation ports with attached 1-way
stopcocks (11)
7. Distal balloon (ECA), with central radiopaque marker,
occlusion range up to Ø 6 mm
8. Proximal balloon (CCA), with central asymmetric marker,
occlusion range up to Ø 13 mm
9. Distal tip valve ("fish-mouth-valve")
10. 3x filter baskets
11. 2x 1-way stopcocks for connection to balloon inflation/
deflation ports (6)
12. 30 cc self-locking syringe
13. T-Safety Connector
0110090-4
Page 2 of 8
Medtronic, Inc., Minneapolis, MN
Manufacturer
Page 3
INSTRUCTIONS FOR USE
DESCRIPTION
The Mo.Ma™ Ultra Proximal Cerebral Protection Device, an
embolic protection device, consists of a tri-lumen shaft (one
working channel and two inflation-deflation lumens), two compliant
balloons, and a handle at the proximal end. Cerebral protection
with the Mo.Ma Ultra is achieved by proximal blood flow blockage
at the carotid bifurcation by occluding the common carotid artery
(CCA) and the external carotid artery (E CA) with the two compliant
balloons (proximal and distal, respectively), which can be
independently inflated. Debris removal is ultimately achieved by
manual (syringe) blood aspiration through the working channel.
Balloons are mounted on the distal portion of the shaft with the
distal balloon close to the tip and the proximal balloon 6 cm from
the distal balloon, just before the exit port of the working channel.
The proximal CCA balloon can be inflated up to 13 mm while the
distal ECA balloon can be inflated up to 6 mm. The hollow mandrel
is intended for insertion into the working channel to improve
trackability over a stiff 0.035” guidewire. The system is compatible
with a 9F introducer sheath, its usable length (distance measured
from the handle to the tip of the catheter) is 95 cm.
The working channel, with a 0.083” internal diameter, serves as a
guiding catheter and as a blood aspiration lumen. The exit-port of
the working channel is located between the two balloons allowing
easy access to the ICA.
Radiopaque markers, indicating the middle of each balloon, assist
with device positioning. In addition, the asymmetry of the proximal
marker assists with correct orientation of the exit-port of the
working channel towards the ICA in order to facilitate guidewire
introduction.
A one way tip-valve located at the distal end of the device prevents
backflow from the ipsilateral ECA to the brain through the ICA.
CONTENTS
One Mo.Ma Ultra Proximal Cerebral Protection Device, one hollow
mandrel, one hemostatic valve with 3-way stopcock and extension
tubing, three 40 µm filter baskets, one 30 cc syringe with male
Luer, one T-safety connector, two 1-way stopcocks.
INDICATIONS FOR USE
The Mo.Ma Ultra Proximal Cerebral Protection Device is indicated
as an embolic protection system to contain and remove embolic
material (thrombus/debris) while performing angioplasty and
stenting procedures involving lesions of the internal carotid artery
and/or the carotid bifurcation.
The reference diameter of the external carotid artery should be
between 3-6 mm and the reference diameter of the common
carotid artery should be between 5-13 mm.
CONTRAINDICATIONS
The Mo.Ma Ultra Proximal Cerebral Protection Device is
contraindicated for use in:
■ patients in whom antiplatelet and/or anticoagulation
therapy is contraindicated
■ patients with severe disease of the ipsilateral common
carotid artery
■ patients who are unable to respond to external questions
and stimuli, or to exert a pressure with the contralateral
hand
■ patients who have severe peripheral vascular disease
preventing femoral access, hemorrhagic or hypercoagulable status and/or inability to obtain hemostasis at
the site of the femoral puncture
■ patients with severe vascular tortuosity or anatomy that
would preclude the safe introduction of the Mo.Ma Ultra
device, a stent system or other procedural devices
■ patients with uncorrected bleeding disorders
WARNINGS
■ The safety and effectiveness of the Mo.Ma Ultra Proximal
Cerebral Protection Device has not been demonstrated
with carotid stent systems other than the ACCULINK
RX ACCULINK® Carotid Stent, XACT® Carotid Stent,
PRECISE® Carotid Stent, PROTÉGÉ® RX Carotid Stent,
and WALLSTENT® Carotid Stent.
®
and
■ The safety and effectiveness of the Mo.Ma Ultra Proximal
Cerebral Protection Device has not been evaluated in
vasculatures other than the carotid.
■ Antiplatelet and anticoagulation therapy should be
administered pre- and post-procedure at a dose deemed
appropriate by a physician.
■ Only interventionalists who have sufficient experience
should carry out carotid artery angioplasty and stenting
aided by proximal flow blockage cerebral protection
devices. A thorough understanding of the technical
principles, clinical applications and risks associated with
carotid artery angioplasty and stenting is necessary before
using this product.
■ The Mo.Ma Ultra Proximal Cerebral Protection Device is
not recommended in patients who cannot tolerate
contrast agents necessary for intraoperative imaging or
who have chronic renal insufficiency.
■ This device is designed and intended for single use only.
DO NOT RESTERILIZE AND/OR REUSE. Reuse or
resterilization may create a risk of contamination of the
device and/or cause patient infection or crossinfection,
including, but not limited to, the transmission of infectious
disease(s) from one patient to another. Contamination of
the device may lead to injury, illness, or death of the
patient. Reuse or resterilization may compromise the
structural integrity of the device and/or lead to device
failure, which, in turn, may result in patient injury, illness,
or death. Medtronic will not be responsible for any direct,
incidental, or consequential damages resulting from
resterilization or reuse.
■ Perform balloon purging as described in this In struction for
Use, before inserting the Mo.Ma Ultra Proximal Cerebral
Protection Device inside the patient.
■ Exercise care during handling and avoid acute bends of
the device before and during the balloon purging
procedure.
■ Avoid positioning the Mo.Ma Ultra Proximal Cerebral
Protection Device without the hollow mandrel.
■ Place the ECA balloon sufficiently deep into the ECA, so
that the distal balloon (ECA balloon) cannot slip back into
the CCA. However, do not place the ECA balloon deeper
than 1.5 cm (measured from the ostium into the ECA) to
avoid CCA proximal balloon interference with the stent
placement.
■ The Mo.Ma Ultra balloons should not be over-inflated.
■ When inflating the occlusive balloons, inflation
confirmation must be made by angiographic visual
estimation of balloon cylindrical shape deformation (not by
pressure).
■ After inflating the two balloons immediately perform
angiographic check of bloo d flow blockage as described in
the CHECK OF FLOW BLOCKAGE section in the
Instructions for Use, and check patient’s clinical tolerance
to occlusion.
■ Should patient intolerance to occlusion occur during the
procedure, immediately remove all debris performing
syringe blood aspirations and deflate the proximal (CCA)
balloon.
■ Before deflating the two occlusion balloons always verify
that no more debris is retrieved in the aspirated blood as
observed in the filter basket.
■ ICA lesion must not be crossed by guidewires or any other
interventional catheters before the two occlusion balloons
have been inflated and before having checked that blood
flow has been effectively blocked.
■ When the Mo.Ma Ultra Proximal Cerebral Protection
Device is exposed to the vascular system, it should be
manipulated while under high-quality fluoroscopic
observation.
■ Do not place the occlusion balloons into highly calcified
vessel segments of the CCA or ECA.
■ Do not manipulate the Mo.Ma Ultra Proximal Cerebral
Protection Device when the occlusive balloons are
inflated.
■ If resistance occurs during manipulation do not force or
continue to manipulate. The reason for the resistance
must first be ascertained by fluoroscopy, road mapping or
DSA before the Mo.Ma Ultra Proximal Cerebr al Protection
Device is moved backwards or forwards.
0110090-4
Page 3 of 8
Medtronic, Inc., Minneapolis, MN
Manufacturer
Page 4
INSTRUCTIONS FOR USE
■ Use only a mixture of contrast medium and saline solution
(50/50) to fill the occlusion balloons. Never use air or any
gaseous medium or pure contrast to inflate the occlusion
balloons.
■ Do not use with Lipiodol or Ethidiol contrast media, or
other such contrast media, which incorporate the
components of these agents.
■ Do not expose the Mo.Ma Ultra Proximal Cerebral
Protection Device to organic solvents, e.g. acetone,
alcohol.
■ Use the Mo.Ma Ultra Proximal Cerebral Protection Device
prior to the Use Before date specified on the package.
PRECAUTIONS
■ Allergic reactions to contrast medium should be identified,
and if possible, treated before the procedure.
■ The general technical requirements for catheter insertion
must be observed at all times. This includes purging the
balloons, flushing the components with sterile, isotonic
saline solution prior to use and the usual prophylactic,
systemic heparinization.
■ Confirm the compatibility of other devices (guidewires,
balloon dilatation catheters, stent delivery systems, etc.)
with the Mo.Ma Ultra Proximal Cerebral Protection Device
before use.
■ Do not use any part of the Mo.Ma Ultra Proximal Cerebral
Protection Device if the package is opened or damaged.
ADVERSE EVENTS
SUMMARY OF CLINICAL RESULTS (G060247)
The objective of the ARMOUR Clinical trial was to assess the
safety and effectiveness of the Mo.Ma Ultra Proximal Cerebral
Protection Device for embolic protection during carotid artery
angioplasty and stenting (CAS) procedures in high surgical risk
patients.
The serious adverse events that were reported by the
investigational sites during the ARMOUR Clinical Trial are
summarized in Table 1. A serious adverse event is any
undesirable event that resulted in death, was life-threatening,
required inpatient hospitalization or prolongation of hospitalization,
required intervention to prevent permanent impairment/damage,
or resulted in persistent or significant disability.
System Organ Class/Preferred Term ITT Population
Any Serious Adverse Event 16.4% (37) 29.7% (11)
Blood and lymphatic system disorders 1.8% (4)
Cardiac disorders 2.2% (5) 5.4% (2)
Gastrointestinal disorders 1.8% (4) 5.4% (2)
General disorders and administration
site conditions
Infections and infestations 0.9%(2)
Table 1 . Site - Reported Serious Adverse Events
(N=225)
Anaemia 1.8% (4)
Coagulopathy 0.4% (1)
Bradycardia 0.9% (2) 2.7% (1)
Cardiac failure congestive 0.4% (1)
Cardio-respiratory arrest 0.4% (1)
Coronary artery disease 0.4% (1)
Ventricular tachycardia 2.7% (1)
Diverticular perforation 2.7% (1)
Gastrointestinal haemorrhage 0.9% (2)
Haematemesis 0.4% (1)
Upper gastrointestinal haemorrhage 0.4% (1) 2.7% (1)
0.9%(2)
Catheter site haemorrhage 0.4% (1)
Multi-organ failure 0.4% (1)
Pneumonia 0.9% (2)
Roll-In
(N=37)
Table 1. Site - Reported Serious Adverse Events
System Organ Class/Preferred Term ITT Population
Injury, poisoning and procedural
complications
Hip fracture 0.4% (1)
Lumbar vertebral fracture 0.4% (1)
Investigations 1.8% (4)
Blood urea increased 0.4% (1)
Ejection fraction abnormal 0.4% (1)
Haemoglobin decreased 0.9% (2)
Musculoskeletal and connective tissue
disorders
Neck pain 0.4% (1)
Neoplasms benign, malignant and
unspecified (incl cysts and polyps)
Lung neoplasm malignant 0.4% (1)
Nervous system disorders 3.6% (8) 5.4% (2)
Carotid artery stenosis 0.4% (1)
Cerebral hyperperfusion syndrome 0.4% (1)
Cerebrovascular accident 0.9% (2)
Confusional state 2.7% (1)
Convulsion 2.7% (1)
Embolic stroke 0.4% (1)
Ischaemic stroke 0.4% (1)
Loss of consciousness 0.4% (1)
Syncope 0.9% (2)
Renal and urinary disorders 2.7% (6)
Renal failure 1.3% (3)
Renal failure acute 0.4% (1)
Urethral stenosis 0.4% (1)
Urinary retention 0.4% (1)
Respiratory, thoracic and mediastinal
disorders
Chronic obstructive pulmonary disease 2.7% (1)
Vascular disorders 4.0% (9) 18.9% (7)
Femoral artery occlusion 2.7% (1)
Hypotension 2.7% (6) 18.9% (7)
Iliac artery occlusion 2.7% (1)
Orthostatic hypotension 0.4% (1)
Vascular pseudoaneurysm 0.9% (2)
POTENTIAL COMPLICATIONS/ADVERSE EFFECTS
The complications that may result from a carotid balloon dilatation
and stenting procedure, aided by a proximal flow blockage
cerebral protection device, include but are not limited to:
Puncture / Access Site related:
■ Local hematoma
■ Local haemorrhage
■ Local or distal thromboembolic episodes
■ Thrombosis
■ Arterio-venous fistula
■ Pseudoaneurysm
■ Local infections
Procedure related:
■ Bradycardia
(N=225)
0.9%(2)
0.4% (1)
0.4% (1)
Roll-In
(N=37)
2.7% (1)
0110090-4
Page 4 of 8
Medtronic, Inc., Minneapolis, MN
Manufacturer
Page 5
INSTRUCTIONS FOR USE
■ Hypotension
■ Carotid artery spasm
■ Dissection of the carotid arteries
■ Air emboli
■ Cerebrovascular accident (Stroke [ischemic,
hemorrhagic], TIA)
■ Acute myocardial infarction
■ Unstable angina
■ Intravascular stent migration
Angiography related:
■ Hyper- /Hypotension
■ Pain and tenderness
■ Arrhythmias
■ Sepsis/infection
■ Systemic embolization
■ Endocarditis
■ Short-term hemodynamic deterioration
■ Death
■ Drug reactions
■ Allergic reaction to contrast medium
■ Pyrogenic reaction
SUMMARY OF CLINICAL RESULTS
The results of this clinical trial support the safety and effectiveness of the
Mo.Ma Ultra Proximal Cerebral Protection Device.
Objective
The objective of the Invatec ARMOUR trial was to evaluate the
safety and effectiveness of the Mo.Ma Ultra Proximal Cerebral
Protection Device in hig h surgical risk subjects undergoing carotid
artery stenting.
Tri al De si gn
Pivotal, prospective, multi-center, non-randomized trial with
sequential enrollment of all qualified subjects undergoing carotid
interventional procedures. All subjects who provided informed
consent and met inclusion/exclusion criteria, underwent
percutaneous revascularization of the carotid artery using the
TM
MO.MA
device and a stent approved by the FDA for carotid
artery stenting. Follow-up took place at pre-discharge and at
30 days post-procedure. Results were compared to a
performance goal of 13% for the 30-day major adverse cardiac
and cerebrovascular events (MACCE) composite rate, which was
derived from previous carotid stenting trials.
Trial Enrollment
A total of 262 subjects (37 roll-in, 225 ITT/pivotal) were enrol led at
25 sites in the United States (20) and the European Union (5)
between September 25, 2007 and February 5, 2009.
Subject Demographics
The Mo.Ma Ultra Proximal Cerebral Protection Device could be
used in subjects eligible for carotid angioplasty and stenting with
stenoses involving the ICA and/or the carotid bifurcation, with an
external carotid artery (ECA) reference vessel diameter 3-6 mm,
and reference diameter of the common carotid artery (CCA)
5-13 mm. Subjects were required to be at least 18 years old and
at high surgical risk for carotid endarterectomy procedures based
on one or more of the criteria listed in Table 2. A target lesion
stenosis ≥ 80% was required for asymptomatic subjects and ≥
50% stenosis for symptomatic subjects. A symptomatic subject
was defined as carotid stenosis associated with ipsilateral
transient or visual TIA evidenced by amaurosis fugax, ipsilateral
hemispheric TIAs or ipsilateral ischemic stroke within 6 months
prior to enrollment. Baseline demographics and clinical
characteristics are summarized in Table 3.
Patient Characteristics ITT Population
Clinical High Surgical Risk Criteria 80.1% (177/221)
Age >75 56.1% (124/221)
CCS angina class 3-4 or unstable angina 4.1% (9/2 21)
Table 2 . High Surgical Risk Criteria
(N=225)
Table 2 . High Surgical Risk Criteria
Patient Characteristics ITT Population
CHF Class III-IV 2.7% (6/221)
LVEF <35% 8.1% (18/221)
MI <6 weeks 0.5% (1/221)
Coronary artery disease with >=2 vessel disease in
major vessel & history of angina
Severe pulmonary disease 4.5% (10/221)
Permanent contralateral cranial nerve injur y 0.0% (0/221)
Anatomical High Surgical Risk Criteria 33.0% (73/221)
High cervical lesion 3.2% (7/221)
Tandemlesions >70% 0.0% (0/221)
Hostile neck 5.0% (11/221)
CEA restenosis 7.7% (17/221)
Cervical immobility due to fusion or arthritis 2.7% (6/221)
Bilateral carotid stenosis, both requiring treatme nt 15.8% (35/221)
Table 3. Baseline Demographics and Clinical Characteristics
Patient Characteristics ITT Population
Age (years)
Mean ± SD (N) 74.7±8.54 (225)
(Min, Max) (42.4, 89.9)
Gender
Male 66.7% (150/225)
Symptomatic 15.1% (34/225)
Asymptomatic 84.9% (191/225)
Age > 75 years 56.1% (12 4/221)
Current Smoker 15.1% (33/219)
Diabetes Mellitus (DM) 37.1% (83/224)
Hypertension 87.1% (196/225)
Hyperlipidemia 81.9% (176/215)
History of renal failure 10.4% (23/221)
Family History of Premature CAD 20.7% (34/164)
Family History of Peripheral Vascular Disease 7.8% (12/153)
Family History of Stroke 25.0% (44/176)
Primary Endpoint and Secondary Endpoints
The ARMOUR trial primary endpoint (MACCE) was a composite
endpoint of any myocardial infarction, stroke, or death at 30 days
post-procedure. Endpoint results are summarized in Table 4.
Endpoints ITT Population
Primary Endpoint
Compositerate of MACCE to
30 days post-procedure
Any myocardial infarction 0.0% (0/220) 0.0% (0/37) 0.0% (0/257)
Stroke 2.3% (5/220) 0.0% (0/37) 1.9% (5/257)
Tabl e 4. : Primary and Secondary Endpoints
(N=220)
2.7% (6/220) 0.0% (0/37) 2.3% (6/257)
Major Ipsilateral Stroke 0.9% (2/220) 0.0% (0/37) 0.8% (2/257)
Major Contralateral Stroke 0.0% (0/220) 0.0% (0/37) 0.0% (0/257)
Minor Ipsilateral Stroke 1.4% (3/220) 0.0% (0/37) 1.2% (3/257)
(N=225)
14.5% (32/221)
(N=225)
Roll-In
(N=37)FA(N=257)
0110090-4
Page 5 of 8
Medtronic, Inc., Minneapolis, MN
Manufacturer
Page 6
INSTRUCTIONS FOR USE
Table 4. : Primary and Secondary E ndpoints
Endpoints ITT Population
Minor Contralateral Stroke 0.0% (0/220) 0.0% (0/37) 0.0% (0/257)
Death 0.9% (2/220) 0.0% (0/37) 0.8% (2/257)
Compositerate of MACCE
during procedure
Compositerate of MACCE at
discharge
Secondary Endpoints
Device Success 98.2% (221/
Technical Success 94.6% (210/
Procedural Success 93.2% (207/
Restenosis at 30 days 1.6% (3/190) 5.9% (2/34)
Target Lesion
Revascularization at
30 days
Access Site Complications 3.1% (7/225) 5.4% (2/37)
Table 5 . Distribution of Stents Used
Manufacturer/Model ITT Population (N of
Cordis PRECISE Nitinol Stent System 35.5% (82/231)
Abbott Acculink and RX Acculink Car otid Stent
System
Abbott XACT Carotid Stent System 34.6% (80/231)
ev3 Protege RX Carotid Stent System 6.1% (14/231)
Boston Scientific Carotid WALLSTENT Monorail
Endoprothesis
(N=220)
1.8% (4/225) 0.0% (0/37) 1.5% (4/262)
1.8% (4/225) 0.0% (0/37) 1.5% (4/262)
225)
222)
222)
0.0% (0/220) 0.0% (0/37)
Roll-In
(N=37)FA(N=257)
100.0% (37/
37)
94.4% (34/
36)
91.7% (33/
36)
patients=225, N of
stents=231)
20.3% (47/231)
3.5% (8/231)
PREPARATION TECHNIQUE
1. Remove the Mo.Ma Ultra Proximal Cerebral Protection
Device from the packaging.
2. Prior to use, carefully examine the entire Mo.Ma Ultra
Proximal Cerebral Protection Device for defects or
damage during shipment.
3. Connect the hemostatic working channel valve to the
proximal port of the connector (1).
4. Flush the working channel with saline solution through the
hemostatic valve and extension tubing.
5. Flush the hollow mandrel with saline solution.
6. Insert the tip of the mandrel through the hemostatic valve
and into the working channel. Advance the mandrel
completely and verify that the tip reaches the exit port and
is positioned at the mid-point of the exit port.
7. Close the hemostatic valve in order to lock the mandrel in
the correct position.
PURGING
1. Prepare the supplied 30 ml syringe by filling with 10 ml
contrast/saline mix (50/50).
2. Connect the syringe to the “distal balloon ECA” luer port
located on the handle of the connector.
3. Keeping the syringe downward, draw vacuum and wait for
at least 15 seconds, until no air bubbles rise from the
device.
4. With keeping the syringe tip downward, return to ambient
pressure (release the syringe plunger).
5. Detach the syringe from the device, leaving a drop of fluid
at the luer port.
Repeat steps 1-5 for the CCA proximal balloon port. The Mo.Ma
Ultra Proximal Cerebral Protection Device is now purged.
DEVICE INSERTION, POSITIONING, ORIENTATION
1. After standard retrograde, femoral access is obtained,
dilate the puncture site for insertion of a 9F long
(approximately 25 cm long) introducer sheath.
2. Under fluoroscopic control, using standard diagnostic
technique, engage the ECA with a 0.035” super-stiff
guidewire.
3. Carefully introduce the proximal section of the 0.035”
guidewire into the white distal tip valve [”fish-mouthvalve”(9)], located on the distal tip of the Mo.Ma
Proximal Cerebral Protection Device. Advance the
Mo.Ma® Ultra system (including mandrel) under
fluoroscopy over the wire through the 9F introducer until
the distal marker (on the ECA balloon) is positioned in the
ECA close to the carotid bifurcation and max. 1.5 cm
distally from the bifurcation ostium.
WARNING: Place the ECA balloon sufficiently deep into
the ECA, so that the distal balloon (ECA balloon) cannot
slip back into the CCA. However, do not place the ECA
balloon deeper than 1.5 cm (measured from the ostium
into the ECA) to avoid CCA proximal balloon interference
with the stent placement.
4. The proper orientation of the working channel exit port
towards the ICA can be checked by the proximal marker
band. This marker band should point towards the ICA
ostium.
5. Once the Mo.Ma Ultra Proximal Cerebral Protection
Device is in place, open the hemostatic valve, remove the
mandrel leaving the 0.035” guidewire in place, then close
the hemostatic valve.
BALLOON INFLATION, FLOW BLOCKAGE
CAUTION: Use only the supplied 30 ml syringe with male Luer
and T-safety connector for inflation of the occlusion balloons. Do
not use the Mo.Ma Ultra Proximal Cerebral Protection Device in
ECA reference diameters > 6 mm and in CCA reference diameters
> 13 mm.
CAUTION: IMPORTANT NOTE ON BALLOON INFLATION
CCA and ECA balloons are highly compliant and are designed to
achieve atraumatic vessel occlusion by changing their shape from
circular to cylindrical. They feature a wide balloon-vessel contact
area and provide the operator with immediate angiographic
feedback that vessel occlusion has been achieved. For this
reason a pressure guided operation of the balloons must not
be performed. Therefore during inflation, the operator must
carefully watch the fluoroscopic image in order to detect the
cylindrical shape deformation of the balloons.
1. Secure the supplied 30 ml syringe filled with 10 cc
contrast/saline mix (50/50) to the T-safety connector.
2. Join the T-safety connector with the 1-way stopcock.
3. Ensure that no air bubbles remain in the syringe, the Tsafety connector and the 1-way stopcock by flushing the
assembly.
4. Attach the assembly to the ECA distal balloon port
previously prepared. Ensure the assembly is securely
connected to the device. With the 1-way stopcock open,
gently inflate the balloon. Confirm proper balloon inflation
under fluoroscopy.
5. If overpressure occurs, a few drops of fluid will escape
from the T-safety connector.
6. As soon as balloon inflation is completed, turn the 1-way
stopcock 90 degrees to the closed-position.
7. With the 1-way stopcock closed, detach the syringe and Tsafety connector.
8. Inject 5 cc contrast through the working channel to ensure
the proper occlusion of the ECA.
9. After proper positioning of the distal balloon in the ECA,
remove the 0.035” guidewire from the ECA.
10. Repeat the same inflation procedure from number 1 to 7
for the proximal CCA balloon.
®
Ultra
0110090-4
Page 6 of 8
Medtronic, Inc., Minneapolis, MN
Manufacturer
Page 7
INSTRUCTIONS FOR USE
CHECK OF FLOW BLOCKAGE
1. After the two occlusion balloons have been inflated,
connect a syringe prepared with contrast/saline mix (50/
50) to the side-port of the working channel.
2. Slowly aspirate 10 cc of blood into the syringe.
3. Under fluoroscopic control, slowly inject 5 cc of contrast/
saline mix and verify that contrast stagnation occurs at the
carotid bifurcation.
NOTE: If the total flow blockage is achieved in the CCA
and ICA, the contrast medium will stagnate in the
occluded segment and can be used as a “road map” for
the adequate positioning of any stent or dilation balloon
catheter.
CAUTION: Ensure that the injection of contrast medium
with a maximum of 5 cc is performed in a slow and
controlled manner. Do not perform further injections until
aspiration steps have been completed.
4. Once contrast stagnation has been verified, cerebral
protection with the Mo.Ma Ultra Proximal Cerebral
Protection Device is achieved, and the carotid artery
procedure can be performed.
CHECK OF PATIENT TOLERANCE
■ Continuously monitor the patient when initiating the CCA
occlusion balloon. Observe the patient’s mental and motor
status. The patient should be able to hear commands,
speak, and move all limbs.
■ Control and maintain patient systemic blood pressure.
Should the patient manifest immediate or delayed
intolerance after inflation of the occlusion balloons,
perform the following: aspirate blood until no more debris
appears in the filter basket to prevent cerebral embolism.
Refer to the section “DEBRIS REMOVAL”.
■ Deflate the proximal balloon (CCA) in order to restore
cerebral blood flow.
■ When the patient’s symptoms have resolved, re-inflate the
proximal balloon in order to check persistence of
intolerance. If intolerance persists, the procedure may be
terminated or an alternative protection device may be
used.
CAUTION: Should the patient not tolerate the occlusion of the
CCA, the operator must first aspirate blood to prevent cerebral
embolism, immediately followed by deflation of the proximal
balloon CCA in order to restore cerebral blood flow.
CAROTID TREATMENT PROCEDURE
■ To treat the diseased ICA, the operator may use all
materials of choice which are compatible with 6F
introducer sheaths. The working channel of the Mo.Ma
Ultra Proximal Cerebral Protection Device has an inner
fully usable lumen diameter of 0.083” (2.12 mm) and is
used as a guiding catheter or sheath for the advancement
and retrieval of guidewires, pre- and post-dilatation
balloon catheters, and carotid stent delivery systems.
■ Carotid angioplasty and stenting are to be performed
according to standard technique and are left to the
operator’s experience and skills.
■ It is mandatory to leave the ICA guidewire across the
treated lesion while the Mo.Ma Ultra Proximal Cerebral
Protection Device is in place.
DEBRIS REMOVAL
CAUTION: At the end of the procedure, perform debris removal by
blood aspiration while the Mo.Ma Ultra Proximal Cerebral
Protection Device system, with fully inflated occlusion balloons, is
still in place.
Before performing blood aspiration, verify that the hemostatic
valve in the proximal port of the working channel is completely
closed.
1. Connect a 20 cc empty syringe (not supplied) to the 3-way
stopcock of the side port of the hemostatic valve (5).
2. Open the stopcock and start to slowly aspirate blood.
CAUTION: During aspiration, carefully monitor the patient
for any symptoms of intolerance.
NOTE: This procedure can be done at any stage during
the intervention but it must be done at minimum, at the end
of the procedure, i.e., following stent deployment or postdilatation of the stented lesion.
3. Slowly aspirate at least 60 cc of blood (3 syringes of
20 cc). Check the last syringe for debris by flushing the
blood content through the supplied filter basket(s). If
debris is visible in the filter basket, aspirate an additional
20 cc of blood and continue to filter until no more debris
can be detected.
WARNING: If no blood can be aspirated through the
working channel, carefully advance a suitable guiding
catheter through the working channel, slightly distal to the
exit port of the working channel. Aspirate 60 cc through
this guiding catheter as noted above in Step 3.
BALLOON DEFLATION
1. Prior to deflation, remove the T-safety connector from
the 30 cc inflation syringe. Alternatively, any other syringe
can be used for deflation.
2. When the absence of any residual debris has been
ensured, deflate the distal balloon (ECA) under
fluoroscopic control by connecting the syringe to the
closed 1-way stopcock of the distal inflation port, opening
the 1-way stopcock and applying negative pressure.
3. Deflate the proximal balloon (CCA) under fluoroscopy by
connecting the syringe to the closed 1-way stopcock of the
distal inflation port, opening the 1-way stopcock and
applying negative pressure.
4. Perform controlled angiography of the carotid artery.
SYSTEM WITHDRAWAL
1. Retract the guidewire out of the working channel.
2. Gently retrieve the Mo.Ma Ultra Proximal Cerebral
Protection Device under fluoroscopic control.
HOW SUPPLIED
The Mo.Ma Ultra Proximal Cerebral Protection Device is supplied
sterile, non-pyrogenic, latex free, and intended for single use only.
The Mo.Ma Ultra Proximal Cerebral Protection Device is sterilized
by ethylene oxide gas. It will remain sterile as long as the
packaging remains unopened and undamaged. It is supplied with
a single pouch. Use product prior to Use Before date printed on the
label.
CAUTION: Do not use if the inner package is open or damaged.
STORAGE
Store at controlled room temperature, in a dry place. Keep away
from sunlight. Do not expose to organic solvents (e.g., acetone,
alcohol). Rotate inventory so that the devices are used prior to the
expiration date on package label.
DISPOSAL
After use, this product may be a potential biohazard. Handle and
dispose of all such devices in accordance with accepted medical
practice and applicable local, regional, and national laws and
regulations.
WARRANTY DISCLAIMER
This product and each component of its system have been
designed, manufactured, tested and packaged with all reasonable
care. The warnings contained in Medtronic’s Instructions For Use
are expressly to be considered as an integral part of this provision.
Medtronic warranties the product until the expiry date indicated on
the same. The warranty is valid provided that the use of the
product was consistent with the Instructions For Use. Medtronic
disclaims any warranty of merchantability or fitness for a particular
purpose of the product. Medtronic is not liable for any direct,
indirect, incidental or consequential damages caused by the
product. Except in the case of fraud or grave fault on Medtronic’s
part, compensation of any damage to the buyer will not, in any
event, be greater than the invoice price of the disputed products.
The guarantee contained in this provision incorporates and
substitutes the legal guarantees for defects and compliance, and
excludes any other possible liability of Medtronic, however
originating, from this product supplied. These limitations of liability
and warranty are not intended to contravene any mandatory
provisions of law applicable. If any clause of the disclaimer is
considered by a competent court to be invalid or to be in conflict
with the applicable law, the remaining part of it shall not be affected
0110090-4
Page 7 of 8
Medtronic, Inc., Minneapolis, MN
Manufacturer
Page 8
INSTRUCTIONS FOR USE
and remain in full force and effect. The invalid clause shall be
substituted by a valid clause which best reflects Medtronic’s
legitimate interest in limiting its liability or warranty. No person has
any authority to bind Invatec to any warranty or liability regarding
this product.
*0110090-4*
© 2012 Medtronic, Inc.
0110090-4
Page 8 of 8
Manufacturer
Medtronic, Inc.
710 Medtronic Parkway
Minneapolis, MN 55432
www.medtronic.com
Tel. (888) 283-7868
Fax (800) 838-3103
Medtronic, Inc., Minneapolis, MN
USA
Manufacturer
Loading...