V12 Product Ordering Information
> Able to be post-dilated
up to 8mm
V12 RX
Ordering Information
Stent
Diameter/
Length
014"
> Able to be post-dilated
**
up to 12mm
•
GUIDEWIRE
Sheath/
Guide
Catheter
Compatibility+
Code #
Code #
80 cm
140 cm
Catheter
Length
Catheter
Length
5 x 16 mm
85229
85278
5 FR/6 FR
5 x 21 mm
85230
85279
5 x 24 mm
85231
6 x 16 mm
V12 OTW
Ordering Information
Stent
Diameter/
Length
035"
•
GUIDEWIRE
Sheath/
Guide
Catheter
Compatibility+
Code #
Code #
80 cm
120 cm
Catheter
Length
Catheter
Length
5 x 16 mm
85340
85350
6 FR/8 FR
5 FR/6 FR
5 x 22 mm
85341
85351
6 FR/8 FR
85280
5 FR/6 FR
5 x 38 mm
85320
85330
7 FR/9 FR
85236
85285
5 FR/6 FR
5 x 59 mm
85321
85331
7 FR/9 FR
6 x 21 mm
85237
85286
5 FR/6 FR
6 x 16 mm
85342
85352
6 FR/8 FR
6 x 24 mm
85238
85287
5 FR/6 FR
6 x 22 mm
85343
85353
6 FR/8 FR
7 x 16 mm
85243
85292
6 FR/7 FR
6 x 38 mm
85322
85332
7 FR/9 FR
7 x 21 mm
85244
85293
6 FR/7 FR
6 x 59 mm
85323
85333
7 FR/9 FR
7 x 24 mm
85245
85294
6 FR/7 FR
7 x 16 mm
85344
85354
7 FR/9 FR
7 x 22 mm
85345
85355
7 FR/9 FR
7 x 38 mm
85324
85334
7 FR/9 FR
7 x 59 mm
85325
85335
7 FR/9 FR
8 x 38 mm
85326
85336
7 FR/9 FR
8 x 59 mm
85327
85337
7 FR/9 FR
9 x 38 mm
85328
85338
7 FR/9 FR
9 x 59 mm
85329
85339
7 FR/9 FR
10 x 38 mm
85360
85364
7 FR/9 FR
10 x 59 mm
85361
85365
7 FR/9 FR
+ Most Common Size Guide Catheters were tested
> Able to be post-dilated
up to 22mm
035"
•
GUIDEWIRE
V12 OTW
Ordering Information
Stent
Diameter/
Length
Code #
Code #
Sheath
Compatibility
80 cm
120 cm
Catheter
Length
Catheter
Length
12 x 29 mm
85370
85379
9 FR
12 x 41 mm
85371
85380
9 FR
12 x 61 mm
85372
85381
9 FR
14 x 29 mm
85373
85382
11 FR
14 x 41 mm
85374
85383
11 FR
14 x 61 mm
85375
85384
11 FR
16 x 29 mm
85376
85385
11 FR
16 x 41 mm
85377
85386
11 FR
16 x 61 mm
85378
85387
11 FR
** 38mm & 59mm lengths only + Most Common Size Guide Catheters were tested
Advanta™ V12 is CE approved for restoring the patency of iliac
and renal arteries. Renal approval is for 5-7mm sizes.
Advanta™ V12 is not available in the U.S.
www.atriummed.com
ATRIUM MEDICAL CORPORATION
ATRIUM EUROPE B.V.
ATRIUM AUSTRALIA-PACIFIC RIM PTY. LTD.
5 Wentworth Drive
Hudson, New Hampshire 03051 U.S.A.
603-880-1433
603-880-6718
Rendementsweg 20 B
3641 SL Mijdrecht, The Netherlands
+31 297 230 420
+31 297 282 653
Level 6, 579 Harris Street
Ultimo NSW 2007 Australia
+61 2 8272 3100
+6 12 8272 3199
© Atrium Medical Corporation 2011. All rights reserved. Printed in U.S.A. 10/11 Part #0467A. Atrium and V12 are trademarks of Atrium Medical Corporation.
Vascular V12
Covered Stent
The New Standard of Care
Innovation
Novel Thermo-Conformable Covered Stent
• 316L stainless steel stent completely encapsulated
in a proprietary one piece ePTFE film cast covering
• Limits cellular ingrowth to help minimize
hyperplasia response
• Helps minimize vessel wall injury with full
encapsulation
• Proprietary fluoropolymer film technology
responds to body temperature
• No FEP adhesive for uniform deployment without
delamination
• Enables embolic entrapment during deployment
Optimized for Exceptional Vessel
Conformability
• Ability to fully customize to target vessel diameter
• Ability to post-dilate and flare with precise,
accurate placement
• Enhanced flexibility with advanced balloon
deployment catheter design
Proven Clinical Superiority
• Over 100,000 patients successfully treated
worldwide
• Over 120 clinical publications
ULTRA LOW PROFILE: AS LOW AS 5 FR
Confidence
Prospective, Randomized, Controlled, Multi-Center (12 sites) clinical trial comparing V12 Covered Stent to Bare Metal Stents for use in
Iliac occlusive disease.
TVR (18 months)
B, C, & D Lesions
Freedom from Restenosis (18 months)
C & D Lesions
Freedom from Occlusion
(18 months) C & D Lesions
V12
3%
88%*
95%*
BMS
16%
46%
88%
COBEST Trial: A comparison of Atrium’s vascular V12 balloon expandable covered stent vs bare metal stents for the treatment of aortoiliac occlusive
disease. Patrice Mwipatayi, MD et al, JVS 2011 (endnote 1)
Kissing Stent Trial
Review of Covered vs. Bare Metal Kissing Stents used to treat Aortoiliac Lesions.
Sustained Clinical
Improvement (2 yrs)
Primary Patency (1 yr)
Primary Patency (2 yrs)
Atrium
covered
stent
84%
92%*
92%*
BMS
54%
78%
62%
Outcomes of Covered Kissing Stent Placement Compared with Bare Metal Stent Placement in the Treatment of Atherosclerotic Occlusive Disease
at the Aortic Bifurcation. Sabri et al, JVIR, July 2010, Volume 21, Number 7.
Renal Fenestration Study
Prospective study that compared outcomes of Covered vs. Bare Metal stents when used along with fenestrated AAA devices during
endovascular repair of abdominal aneurysms.
Number of Patients
Renal Occlusion Rate (2 yrs)
Overall Renal Restenosis/
Occlusion Rate (2 yrs)
Bx Covered Stents
129
2.2%*
5%*
BMS
158
4.5%
17%
1. Revised Duplex Criteria and Outcomes for Renal Stents and Stent Grafts Following Endovascular Repair of Juxtarenal and Thoracoabdominal
Aneurysms. Greenberg et al. JVS, April 2009.
Renal Restenosis Study
Review of Atrium balloon expandable PTFE covered stent placement for the treatment of renal artery in-stent restenosis.
Procedural Success
Number of Renal Arteries Treated
In-Stent Restenosis (~1 yr)
100%
30
0%
Atrium
covered
stent
The Utilization of PTFE Covered Stents for the Treatment of Renal Artery In-Stent Restenosis. Ansel et al. JACC, March 2010, Volume 55, Issue 10A.
*Statistically significant
CLINICAL SUPERIORITY TO BMS
Dependable
Iliac Occlusive Disease >
The preferred treatment option for
complex iliac occlusive disease.
Left common iliac total
occlusion and right
common iliac disease
Post deployment of
8mm x 59mm V12 in right
common iliac and
8mm x 38mm V12 in
left common iliac
Significant bilateral
iliac disease
Excellent result after two
8mm x 59mm V12 kissing
stents deployed
Total occlusion of the aorta
and bilateral iliac arteries
Patency restored post
V12 deployment in distal
aorta and bilateral iliac
arteries
Bilateral Iliac Occlusive Disease >
Superior outcomes for the
treatment of complex
atherosclerotic aorto-iliac
bifurcation disease.
Aorto-Iliac Occlusive Disease >
Advanced technology for
endovascular repair of aorto-iliac
occlusive disease.
SECURITY: PRECISE & CONFIDENT DEPLOYMENT
Outcomes
Renal Fenestration >
“Covered renal stents are associated with a lower incidence of
in-stent stenosis and are thus recommended over bare metal
stents...” 1
Bilateral renal fenestrations
with V12 covered stents
Severe renal
bilateral stenosis
Renal Stenosis >
Optimal treatment strategy for renal artery
stenosis. PTFE stent encapsulation minimizes
neointimal in-growth and renal restenosis.
Bilateral V12 stents
deployed in renal arteries
Renal Bare Metal
Restenosis >
Highly effective treatment
for restoring perfusion into
the kidney post bare metal
restenosis.
Left renal artery BMS
restenosis
Reperfusion to kidney
achieved post V12 deployment
OVER 100,000 PATIENTS
SUCCESSFULLY TREATED
Emergent Applications
Coarctation of the aorta*
Final result after 12mm x 41mm LD V12
deployed and post dilated to 14mm
Coarctation of the aorta*
Final result after 16mm x 41mm LD V12
deployed and post dilated to 18mm
*V12 is currently under investigation for the treatment of aortic coarctation
TRUST: V12’s SUPERIOR COVERING
TECHNOLOGY
Versatility
•
•
•
•
Large Diameters 12,14 & 16mm, Lengths 29, 41 & 61mm
Low Profile
.035” Guidewire Compatible
Ability to Post Dilate to 22mm
•
•
•
•
•
Diameter 5-7mm, Lengths 16, 21, & 24mm
Ultra Low Profile
.014” Guidewire Compatible
Ability to Post Dilate to 8mm
Superior Deliverability in Small Vessels and
Tortuous Anatomy
•
•
•
•
Diameters 5-10mm, Lengths 16, 22, 38 & 59mm
Low Profile
.035” Guidewire Compatible
Ability to Post Dilate to 12mm
EXTREME EXPANSION RANGE