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
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 Bilateral Iliac Occlusive Disease > Superior outcomes for the treatment of complex atherosclerotic aorto-iliac bifurcation disease. Significant bilateral iliac disease Excellent result after two 8mm x 59mm V12 kissing stents deployed Aorto-Iliac Occlusive Disease > Advanced technology for endovascular repair of aorto-iliac occlusive disease. Total occlusion of the aorta and bilateral iliac arteries Patency restored post V12 deployment in distal aorta and bilateral iliac arteries 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, s 29, 41 & 61mm Low Profile.035 Guidewire Compatible Ability to Post Dilate to 22mm Diameter 5-7mm, s 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, s 16, 22, 38 & 59mm Low Profile.035 Guidewire Compatible Ability to Post Dilate to 12mm *6 & 7mm diameters are capable of post-dilation to 8mm **38 & 59mm lengths only EXTREME EXPANSION RANGE
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) V12 3% 88%* 93% BMS 16% 46% 82% 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) Atrium covered stent 100% 30 0% 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
V12 Product Ordering Information > Able to be post-dilated up to 8mm * 014" GUIDEWIRE > Able to be post-dilated up to 12mm ** 035" GUIDEWIRE Stent Diameter/ V12 RX Ordering Information Code # 80 cm Code # 140 cm Sheath/ Guide Compatibility + Stent Diameter/ V12 OTW Ordering Information Code # 80 cm Code # 120 cm Sheath/ Guide Compatibility + 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 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 + Most Common Size Guide s were tested * 6 & 7mm diameters are capable of post-dilation to 8mm > Able to be post-dilated up to 22mm 035" GUIDEWIRE 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 Stent Diameter/ V12 OTW Ordering Information Code # Code # Sheath Compatibility 80 cm 120 cm 12 x 29 mm 85370 85379 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 ** 38mm & 59mm lengths only + Most Common Size Guide s were tested 12 x 41 mm 85371 85380 9 FR 12 x 61 mm 85372 85381 9 FR 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. 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 Visit us online at www.atriummed.com 16 x 61 mm 85378 85387 11 FR ATRIUM MEDICAL CORPORATION ATRIUM EUROPE B.V. ATRIUM AUSTRALIA-PACIFIC RIM PTY. LTD. 5 Wentworth Drive Rendementsweg 20 B Level 6, 579 Harris Street Hudson, New Hampshire 03051 U.S.A. 3641 SL Mijdrecht, The Netherlands Ultimo NSW 2007 Australia 603-880-1433 603-880-6718 +31 297 230 420 +31 297 282 653 +61 2 8272 3100 +61 2 8272 3199 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.