vascular v12 - canadian hospital specialtiesbms 54% 78% 62% prospective, randomized, controlled,...
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The New Standard of Care
Vascular V12Covered Stent
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 VesselConformability
• 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
Dependable
SECURITY: PRECISE& CONFIDENT DEPLOYMENT
Left common iliac totalocclusion and right
common iliac disease
Significant bilateraliliac disease
Total occlusion of the aortaand bilateral iliac arteries
Patency restored postV12 deployment in distalaorta and bilateral iliac
arteries
Excellent result after two8mm x 59mm V12 kissing
stents deployed
Post deployment of8mm x 59mm V12 in right
common iliac and8mm x 38mm V12 inleft common iliac
The preferred treatment option forcomplex iliac occlusive disease.
Iliac Occlusive Disease >
Superior outcomes for thetreatment of complexatherosclerotic aorto-iliacbifurcation disease.
Bilateral Iliac Occlusive Disease >
Advanced technology forendovascular repair of aorto-iliacocclusive disease.
Aorto-Iliac Occlusive Disease >
Outcomes
“Covered renal stents are associated with a lower incidence ofin-stent stenosis and are thus recommended over bare metalstents...”1
Optimal treatment strategy for renal arterystenosis. PTFE stent encapsulation minimizesneointimal in-growth and renal restenosis.
Bilateral renal fenestrationswith V12 covered stents
Severe renalbilateral stenosis
Left renal artery BMSrestenosis
Reperfusion to kidneyachieved post V12 deployment
Bilateral V12 stentsdeployed in renal arteries
Highly effective treatmentfor restoring perfusion intothe kidney post bare metalrestenosis.
Renal Stenosis >
Renal Bare MetalRestenosis >
OVER 100,000PATIENTSSUCCESSFULLY TREATED
Renal Fenestration >
Coarctation of the aorta* Final result after 12mm x 41mm LD V12deployed and post dilated to 14mm
Coarctation of the aorta* Final result after 16mm x 41mm LD V12deployed and post dilated to 18mm
TRUST: V12’s SUPERIOR COVERINGTECHNOLOGY
*V12 is currently under investigation for the treatment of aortic coarctation
Emergent Applications
Versatility
• Diameters 5-10mm, Lengths 16, 22, 38 & 59mm• Low Profile• .035” Guidewire Compatible• Ability to Post Dilate to 12mm
• Diameter 5-7mm, Lengths 16, 21, & 24mm• Ultra Low Profile• .014” Guidewire Compatible• Ability to Post Dilate to8mm*
• Superior Deliverability in Small Vessels andTortuous Anatomy
• Large Diameters 12,14 & 16mm, Lengths 29, 41 & 61mm • Low Profile• .035” Guidewire Compatible• Ability to Post Dilate to 22mm
EXTREME EXPANSION RANGE
*6 & 7mm diameters are capable of post-dilation to 8mm
**38 & 59mm lengths only
COBEST Trial: A comparison of Atrium’s vascular V12 balloon expandable covered stent vs bare metal stents for the treatment of aortoiliac occlusivedisease. Patrice Mwipatayi, MD et al, JVS 2011 (endnote 1)
TVR (18 months)B, C, & D Lesions
Freedom from Restenosis (18 months)C & D Lesions
Freedom from Occlusion(18 months)
V12 3% 88%* 93%
BMS 16% 46% 82%
Kissing Stent TrialReview of Covered vs. Bare Metal Kissing Stents used to treat Aortoiliac Lesions.
Outcomes of Covered Kissing Stent Placement Compared with Bare Metal Stent Placement in the Treatment of Atherosclerotic Occlusive Diseaseat the Aortic Bifurcation. Sabri et al, JVIR, July 2010, Volume 21, Number 7.
Sustained ClinicalImprovement (2 yrs)
Primary Patency (1 yr) Primary Patency (2 yrs)
Atriumcoveredstent
84% 92%* 92%*
BMS 54% 78% 62%
Prospective, Randomized, Controlled, Multi-Center (12 sites) clinical trial comparing V12 Covered Stent to Bare Metal Stents for use inIliac occlusive disease.
Renal Fenestration StudyProspective study that compared outcomes of Covered vs. Bare Metal stents when used along with fenestrated AAA devices duringendovascular repair of abdominal aneurysms.
1. Revised Duplex Criteria and Outcomes for Renal Stents and Stent Grafts Following Endovascular Repair of Juxtarenal and ThoracoabdominalAneurysms. Greenberg et al. JVS, April 2009.
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%
Renal Restenosis StudyReview of Atrium balloon expandable PTFE covered stent placement for the treatment of renal artery in-stent restenosis.
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
Procedural Success Number of Renal Arteries Treated In-Stent Restenosis (~1 yr)
Atriumcoveredstent
100% 30 0%
Confidence
CLINICAL SUPERIORITY TO BMS
V12 Product Ordering Information
©Atrium Medical Corporation 2012. All rights reserved. Printed in U.S.A. 4/12 Part #0467B. Atrium and V12 are trademarks of Atrium Medical Corporation, a MAQUET GETINGE GROUP Company.
Advanta™ V12 is CE approved for restoring the patency of iliacand renal arteries. Renal approval is for 5-7mm sizes.
Advanta™ V12 is not available in the U.S.
ATRIUM MEDICAL CORPORATION ATRIUM EUROPE B.V. ATRIUM AUSTRALIA-PACIFIC RIM PTY. LTD.5 Wentworth Drive Rendementsweg 20 B Level 6, 579 Harris StreetHudson, New Hampshire 03051 U.S.A. 3641 SL Mijdrecht, The Netherlands Ultimo NSW 2007 Australia603-880-1433 603-880-6718 +31 297 230 420 +31 297 282 653 +61 2 8272 3100 +61 2 8272 3199
StentDiameter/Length
V12 OTWOrdering Information Sheath/
GuideCatheter
Compatibility+Code #80 cmCatheterLength
Code #120 cmCatheterLength
5 x 16 mm 85340 85350 6 FR/8 FR
5 x 22 mm 85341 85351 6 FR/8 FR
5 x 38 mm 85320 85330 7 FR/9 FR
5 x 59 mm 85321 85331 7 FR/9 FR
6 x 16 mm 85342 85352 6 FR/8 FR
6 x 22 mm 85343 85353 6 FR/8 FR
6 x 38 mm 85322 85332 7 FR/9 FR
6 x 59 mm 85323 85333 7 FR/9 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
StentDiameter/Length
V12 OTWOrdering Information
SheathCompatibilityCode #
80 cmCatheterLength
Code #120 cmCatheterLength
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
StentDiameter/Length
V12 RXOrdering Information Sheath/
GuideCatheter
Compatibility+Code #80 cmCatheterLength
Code #140 cmCatheterLength
5 x 16 mm 85229 85278 5 FR/6 FR
5 x 21 mm 85230 85279 5 FR/6 FR
5 x 24 mm 85231 85280 5 FR/6 FR
6 x 16 mm 85236 85285 5 FR/6 FR
6 x 21 mm 85237 85286 5 FR/6 FR
6 x 24 mm 85238 85287 5 FR/6 FR
7 x 16 mm 85243 85292 6 FR/7 FR
7 x 21 mm 85244 85293 6 FR/7 FR
7 x 24 mm 85245 85294 6 FR/7 FR
> Able to be post-dilatedup to 12mm**
> Able to be post-dilatedup to 8mm*
+ Most Common Size Guide Catheters were tested* 6 & 7mm diameters are capable of post-dilation to 8mm
** 38mm & 59mm lengths only + Most Common Size Guide Catheters were tested
> Able to be post-dilatedup to 22mm
•035"GUIDEWIRE
•035"GUIDEWIRE
•014"GUIDEWIRE
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