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03/14

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 P R O v e N D e si g n
& P e rform a nc e
Proven design and performance of the Valiant Captivia System now The Valiant Captivia System with proximal FreeFlo tapers continues
offers broader options to treat a wide range of patient anatomies. to deliver the proven performance with additional components for
broad patient suitability.

21% of patients in VALOr II trial (N=160)

presented tapered aortas. THE Valiant
Captivia System with proximal FreeFlo
tapers helps you treat more anatomies
with confidence.*

1. Proven design 2. Additional

with enhanced components to
conformability treat a wide range
and kink resistance of anatomies

3. Tip capture for accuracy 4. Consistent clinical

of positioning performance across a
variety of pathologies

2 V a l iant t h o racic stent g raft W I T H T H E C aptivia D e l iver y S y stem *Data on file at Medtronic, Inc. 3
 confid e nc e
in control
The Valiant Captivia System features tip capture of the proximal
stent. Tip capture provides controlled deployment and placement
when navigating the thoracic aorta.

CO NTROLL E D D E P LOYM E N T W I T H T I P C A P T U R E

Deployment Captured Released

PLACEMENT RELEASE

Tip capture provides After tip capture is released,

accurate stent the Valiant Captivia System
graft placement conforms to the patient’s anatomy

4 V a l iant t h o racic stent g raft W I T H T H E C aptivia D e l iver y S y stem 5

 CONFORMABILIT Y
& O P T I M A L S EA L
The Valiant Captivia System is designed to conform to the thoracic aorta.
The sinusoidal shape and placement of nitinol springs provide flexibility and
conformability to the anatomy. The Valiant Stent Graft is the only device that
maintains complete apposition regardless of angulation and oversizing.*

AN G U L ATI O N 
PRE
Angular flexibility & radial strength give
the Valiant Captivia stent optimal seal*
Results: The Valiant stent
3.5
graft remained apposed
L ACK OF A PPOSITION mm)

3 R E L AY ™ to the aortic wall at each

T X2 ®
PROFORM increment of neck angulation
2.5 and degree of oversizing in
a simulated environment.
2

1.5 For the other stent grafts

C  TAG ®
tested, lack of device wall
1 apposition was observed
between the proximal
0.5 anchorage segment and 3D reconstruction of patient anatomy
0
VALIANT™ 0% the inferior aortic wall.
70 80 90 100 110 120 130 140
AN G U L ATI O N 

POST
Proximal Apposition at Different Body Apposition at Different
Product Tested
Landing Zone Angulation Landing Zone Angulation

No lack of apposition No lack of apposition

Medtronic Valiant® (remained apposed) (remained apposed)

No lack of apposition
Gore® C-TAG® Lack of apposition above 120°
(remained apposed)

No lack of apposition
Bolton RelayTM Lack of apposition above 110°
(remained apposed)

Cook® Zenith® TX2® No lack of apposition

Lack of apposition above 110°
Pro-Form (remained apposed)

Test data not indicative of clinical performance Fluoro shot of post index
procedure result
*Ludovic Canaud, Philipe Cathala, Pierre Alric, Pascal Branchereau, Charles Henri Marty-Ané, (2013) Improvement in conformability of the latest
generation of thoracic stent grafts. Journal of Vascular Surgery: April 2013, Vol. 57, No. 4

Pre and post-procedure images courtesy of The Heart Hospital Baylor Plano

6 V a l iant t h o racic stent g raft W I T H T H E C aptivia D e l iver y S y stem 7

 O P T I M I zE D A C C E S S
The Valiant Captivia System features a crossing profile similar
to or lower than other thoracic stent grafts. Ease of access
means control at every step, across a broad range of anatomies.

Hydrophilic coating to facilitate stent graft delivery EASY THREE–STEP DEPLOYMENT PROCESS

Step 1.
TIP CAPTURE RELEASE HANDLE Slow, controlled deployment for
Simple turn-and-pull motion for tip release precise stent graft placement

Device Outer Diameter Profiles

Step 2.
Quick deployment
Medtronic Bolton
Cook®Zenith®
Gore® C-TAG® option if desired
TX2®
Valiant® Relay® Pro-Form

Crossing Profile
(OD)*
24F 24F 26F 27F

Hydrophilic Coating Yes Yes No No

Step 3.
Sheath Required No No Yes Yes Tip capture release
System OD for Gore C-TAG & Cook Zenith list the OD of sheath as their IFUs recommend the use of a sheath. The System OD for Medtronic Valiant and Bolton
Relay list the OD of the delivery catheter as the use of a sheath is not required per the respective IFUs.
* 36 mm diameter graft used for comparison for all manufacturers except Gore. A 37 mm diameter graft used for Gore since no 36 mm diameter graft exists.

8 V a l iant t h o racic stent g raft W I T H T H E C aptivia D e l iver y S y stem 9

 DURABLE DESIGN
The Valiant Captivia System is built on Medtronic’s 15 years
of thoracic stent graft experience and is proven in more than 1 2
50,000 implants. Our advanced design enhances confidence.*

1. Proximal 8-Peak 2. F
 igur8 Markers for
FreeFlo Configuration Accurate Placement
Evenly distributes radial Platinum iridium markers
force over multiple apices provide high visibility

3. Enhanced Conformability
Absence of longitudinal bar 4. B road Selection of Pieces
allows for enhanced flexibility B road selection of proximal
and kink resistance and distal components
* Test data on file at Medtronic, Inc. Bench test results may not be indicative of clinical performance.
leads to many combinations
to customize for a variety
of patients
10 V a l iant t h o racic stent g raft W I T H T H E C aptivia D e l iver y S y stem 11
 C L I N I C A L D ATA
BUILDING CONFIDENCE
Proven performance across a variety of thoracic pathologies

U.S. MEDTRONIC DISSECTION TRIAL the Valiant Captivia System successfully treats
Prosp ec t ive, non-randomi ze d, m u l ti - ce nte r tr i al a broad range of pathologies and anatomies
Outcomes of tevar in acute, type b aortic dissection: Comprehensive clinical studies and registries now support the use of
results from the valiant® us ide trial (N=50) TEVAR in patients with aortic dissections.
30-day and 1-year results

MEDTRONIC CLINICAL DATA SUPPORTS THE USE OF TEVAR

The Valiant® Captivia® system demonstrates safety and effectiveness in the ACROSS MULTIPLE PATHOLOGIES
treatment of acute, complicated Type B aortic dissections.
# PATIENTS
CLINICAL TRIAL/STUDY ENROLLED TRIAL STUDY DESIGN

Medtronic U.S. Dissection Trial

demonstrates positive aortic remodeling of stented segment
VALOR
(The Talent thoracic stent graft*)
195 Prospective, non-randomized, multi-center U.S. IDE
study conducted to evaluate the safety and
effectiveness of the Talent stent graft system in
patients with descending thoracic aneurysms

6% Decrease
INSTEAD-XL
(The Talent thoracic stent graft)
140 Prospective, randomized controlled trial evaluating
TEVAR+Optimal Medical Therapy vs Medical Therapy
100% 15%
alone in uncomplicated Type B aortic dissections
100% of eligible patients

– Increase
80%
– Stable VALOR II
(The Valiant stent graft)
160 Prospective, non-randomized, multi-center U.S. IDE
study conducted to evaluate the safety and
60%
85% 94% 97% 100% effectiveness of the Valiant stent graft system in
–
patients with descending thoracic aneurysms
40%
–
20%
VIRTUE
(The Valiant stent graft)
100 Prospective, non-randomized multi-center European
registry evaluating Valiant in Type B aortic dissections
– 3%
0%
100
6 months 12 months 6 months 12 months
VALIANT CAPTIVIA REGISTRY Multi-center, non-interventional, single arm registry.
(The Valiant Captivia system) Mid to high risk all comer cohort
False Lumen Volume True Lumen Volume
RESCUE
(The Valiant Captivia system)
50 Prospective, non-randomized, multi-center U.S. IDE
trial to evaluate device performance in blunt thoracic
aortic injury
8% all-cause mortality at 30D met primary safety endpoint
Medtronic U.S. DISSECTION Trial 50 Prospective, non-randomized, multi-center U.S. IDE trial
Evidence 100% delivery and deployment success at implant (The Valiant Captivia system) to evaluate device performance in acute, complicated
Type B aortic dissections
HIghlights 100% coverage of primary entry tear at implant
*The Talent® thoracic stent graft is no longer commercially available in the U.S.
0% ruptures at 30 days and 12 months

Source: Valiant Captivia Instructions for Use, Summary of Clinical Studies

12 V a l iant t h o racic stent g raft W I T H T H E C aptivia D e l iver y S y stem 13

 C ompon e nt pl a c e m e nt g uid e
PROXIMA L FREEFLO STRAIG H T C LOSED WE B STRAIG H T
Produc t Code Produc t Code

Proximal Distal Catheter Stent Stent

Graft Proximal Distal Catheter

And P roduct cod e s

Graft Graft Distal Outer Graft
Graft Graft Distal Outer
Diameter Diameter Design Diameter Covered
Length Diameter Diameter Design Diameter
Covered
(mm) (mm) (F) Length
(mm) (mm) (mm) (F)
(mm)
VAMF 22 22 C 100 TU 22 112 VAMC 22 22 C 100 TU 22 105
VAMF 24 24 C 100 TU 22 112 VAMC 24 24 C 100 TU 22 105
VAMF 26 26 C 100 TU 22 112 VAMC 26 26 C 100 TU 22 105
VAMF 28 28 C 100 TU 22 117 VAMC 28 28 C 100 TU 22 110
VAMF 30 30 C 100 TU 22 117 VAMC 30 30 C 100 TU 22 110
VAMF 32 32 C 100 TU 22 117 VAMC 32 32 C 100 TU 22 110
VAMF 34 34 C 100 TU 24 107 VAMC 34 34 C 100 TU 24 100
VAMF 36 36 C 100 TU 24 107 VAMC 36 36 C 100 TU 24 100
VAMF 38 38 C 100 TU 24 107 VAMC 38 38 C 100 TU 24 100
22 – 46 mm 26 – 46 mm VAMF 40 40 C 100 TU 24 107 VAMC 40 40 C 100 TU 24 100
VAMF 42 42 C 100 TU 25 112 VAMC 42 42 C 100 TU 25 105
VAMF 44 44 C 100 TU 25 112 VAMC 44 44 C 100 TU 25 105
VAMF 46 46 C 100 TU 25 112 VAMC 46 46 C 100 TU 25 105
VAMF 22 22 C 150 TU 22 152 VAMC 22 22 C 150 TU 22 145
VAMF 24 24 C 150 TU 22 152 VAMC 24 24 C 150 TU 22 145
~12 mm ~12 mm VAMF 26 26 C 150 TU 22 152 VAMC 26 26 C 150 TU 22 145
8 Peak 8 Peak VAMF 28 28 C 150 TU 22 157 VAMC 28 28 C 150 TU 22 150
8 8 8 8 VAMF 30 30 C 150 TU 22 157 VAMC 30 30 C 150 TU 22 150
VAMF 32 32 C 150 TU 22 157 VAMC 32 32 C 150 TU 22 150
VAMF 34 34 C 150 TU 24 167 VAMC 34 34 C 150 TU 24 160
VAMF 36 36 C 150 TU 24 167 VAMC 36 36 C 150 TU 24 160
VAMF 38 38 C 150 TU 24 167 VAMC 38 38 C 150 TU 24 160
22 – 46 mm 26 – 46 mm 22 – 46 mm VAMF 40 40 C 150 TU 24 167 VAMC 40 40 C 150 TU 24 160
VAMF 42 42 C 150 TU 25 157 VAMC 42 42 C 150 TU 25 150
(Proximal component)
(Proximal component)

8 VAMF 44 44 C 150 TU 25 157 VAMC 44 44 C 150 TU 25 150

FreeFLO Straight

FreeFlo TapeRED

8 VAMF 46 46 C 150 TU 25 162 VAMC 46 46 C 150 TU 25 155

107 – 212 mm

152–167mm

VAMF 30 30 C 200 TU 22 192 VAMC 30 30 C 200 TU 22 185

VAMF 32 32 C 200 TU 22 192 VAMC 32 32 C 200 TU 22 185

8 8 8 8 8 8 VAMF 34 34 C 200 TU 24 212 VAMC 34 34 C 200 TU 24 205

VAMF 36 36 C 200 TU 24 207 VAMC 36 36 C 200 TU 24 200
VAMF 38 38 C 200 TU 24 207 VAMC 38 38 C 200 TU 24 200
VAMF 40 40 C 200 TU 24 212 VAMC 40 40 C 200 TU 24 205
VAMF 42 42 C 200 TU 25 207 VAMC 42 42 C 200 TU 25 200
VAMF 44 44 C 200 TU 25 212 VAMC 44 44 C 200 TU 25 205

DISTAL BArE SPRING STRaight

VAMF 46 46 C 200 TU 25 212 VAMC 46 46 C 200 TU 25 205

(distal component)
PROXIMA L FREEFLO TAPERED DISTA L BARE SPRING STRAIG H T
0 0 8 8 107 – 117 mm 8
closed web Straight

closed web tapered

Produc t Code
(distal component)

Produc t Code
(distal component)

Stent Stent
Proximal Distal Catheter Proximal Distal Catheter
Graft Graft
100 – 205 mm

150 – 160 mm

Graft Graft Distal Outer Graft Graft Distal Outer

Covered Covered
Diameter Diameter Design Diameter Diameter Diameter Design Diameter
Length Length
(mm) (mm) (F) (mm) (mm) (F)
(mm) (mm)
VAMF 26 22 C 150 TU 22 152 VAMC 22 22 B 100 TU 22 112
VAMF 28 24 C 150 TU 22 157 VAMC 24 24 B 100 TU 22 112
22 – 46 mm 22 – 42 mm VAMF 30 26 C 150 TU 22 157 VAMC 26 26 B 100 TU 22 112
VAMF 32 28 C 150 TU 22 157 VAMC 28 28 B 100 TU 22 117
VAMF 34 30 C 150 TU 24 167 VAMC 30 30 B 100 TU 22 117
VAMF 36 32 C 150 TU 24 167 VAMC 32 32 B 100 TU 22 117
VAMF 38 34 C 150 TU 24 167 VAMC 34 34 B 100 TU 24 107
0 VAMF 40 36 C 150 TU 24 167 VAMC 36 36 B 100 TU 24 107
~12 mm VAMF 42 38 C 150 TU 25 157 VAMC 38 38 B 100 TU 24 107
Distinct radiopaque markers 8 Peak
VAMF 44 40 C 150 TU 25 157 VAMC 40 40 B 100 TU 24 107
8 Figur8 marker VAMF 46 42 C 150 TU 25 162 VAMC 42 42 B 100 TU 25 112
VAMC 44 44 B 100 TU 25 112
0 Zer0 marker 0 0 C LOSED WE B TAPERED VAMC 46 46 B 100 TU 25 112
Produc t Code
Stent
Proximal Distal Catheter
22 – 46 mm Graft Graft Distal Outer
Graft
Covered
Diameter Diameter Design Diameter
Length
(mm) (mm) (F)
(mm)

22 – 42 mm VAMC 26 22 C 150 TU 22 150

22 – 46 mm
VAMC 28 24 C 150 TU 22 150
VAMC 30 26 C 150 TU 22 150
VAMC 32 28 C 150 TU 22 150
VAMC 34 30 C 150 TU 24 160
VAMC 36 32 C 150 TU 24 160
VAMC 38 34 C 150 TU 24 160
VAMC 40 36 C 150 TU 24 160
VAMC 42 38 C 150 TU 25 150
14 V a l iant t h o racic stent g raft W I T H T H E C aptivia D e l iver y S y stem VAMC 44 40 C 150 TU 25 150 15
VAMC 46 42 C 150 TU 25 155