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Helmut Schühlen , M.D., FESC, FACC Deutsches Herzzentrum München, Germany on behalf of the MULTI-LINK VISION Registry

The MULTI-LINK RX VISION  Coronary Stent System. Helmut Schühlen , M.D., FESC, FACC Deutsches Herzzentrum München, Germany on behalf of the MULTI-LINK VISION Registry Investigators . The MULTI-LINK ® Family H istory. Wish List for a New Stent. d e sign a stent system that…

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Helmut Schühlen , M.D., FESC, FACC Deutsches Herzzentrum München, Germany on behalf of the MULTI-LINK VISION Registry

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  1. The MULTI-LINK RX VISIONCoronary Stent System Helmut Schühlen, M.D., FESC, FACC Deutsches Herzzentrum München, Germany on behalf of the MULTI-LINK VISION Registry Investigators

  2. The MULTI-LINK® Family History

  3. Wish List for a New Stent • design a stent system that… • is even more deliverable than current stent technology • incorporates thin struts and less metal with no compromise to radial strength and scaffolding • maintains the acceptable radiopacity of current stents with less metal.

  4. The MULTI-LINK VISIONCoronary Stent • flexible stent design • based on the original MULTI-LINK® Stent • low profiles – IDE • 3.0mm = 0.99 mm (0.039”) • 4.0mm = 1.04 mm (0.041”) • cobald chromium alloy

  5. The MULTI-LINK VISIONCoronary Stent minimized unsupported surface area ML Vision™ 2.5-3.0 mm 6 crests / circumference 3-3-3 pattern 3.8 mm2 U.S.A. at 3.0 mm ML Vision™ 3.5-4.0 mm 9 crests / circumference 3-3-3 pattern 3.8 mm2 U.S.A. at 3.5 mm

  6. The MULTI-LINK VISIONCoronary Stent new electro-polishingprocess

  7. Why Cobalt Chromium? • history of use in humans • over 30 years as a cage for Björk-Shiley heart valves • orthopedics: fixation cable in trochanteric osteotomy (Zimmer) • stronger material than stainless steel • ultimate tensile strength:Co-Cr 161 ksi, 316L 94 ksi • helps maintain radiopacity of current 316 L stents with significantly thinner stent struts

  8. Alloy Comparison both CoCr and 316L have a chromium oxide layer

  9. CoCr Allows a Reduced Strut Thickness ML Vision™ 80 µm (.0032”) ML (1st gen.) 50 µm (.0020”) ML Duet™140 µm (.0055”) ML Penta™ 90-125 µm (.0035-.0050”) BX Velocity™140 µm(.0055”) Express 2™ 130 µm(.0052”) S7™125 µm (.0050”)

  10. Thin Struts with Radiopacity MULTI-LINK 3.5 x 25mm 50 µm ML VISION 3.5 x 23mm 80 µm ML PENTA 3.5 x 23mm 90-125 µm

  11. MULTI-LINK VISION Stent Registry POST PRE

  12. Goal to demonstrate the clinical safety and efficacy of the MULTI-LINK VISIONTMCoronary Stent System

  13. Study Design prospective, open-label, multi-center registry 22 clinical sitesUnited States Europe Asia / Pacific enrollment of 265 patients with • de-novo lesion in native coronary artery • vessel diameter 3.0 – 4.0 mm • lesion length 25mm

  14. MULTI-LINK VISION Stent Registry Principle Investigators: Dean J. Kereiakes, M.D. The Lindner Center/ Ohio Heart Health Center, Cincinnati, OH David A. Cox, M.D. Mid Carolina Cardiology, Charlotte, NC Clinical Events Committee: Kenneth Mahaffey, MD Duke Clinical Research Institute, Durham, NC Angiographic Core Lab: Alexandra Lansky, M.D. Cardiovascular Research Foundation, New York, NY

  15. Patient Characteristics patients 267 (297 stents) age 63.610.7 yrs male 68 % diabetes on Rx 23 % hypertension on Rx 61 % smoking 24 % hyperlipidemia on Rx 64 % prior myocardial infarction 33 % angina class III or IV 36 % prior CABG 4 %

  16. Angiographic Data # Vessel Disease Target Vessel Ramus 2% Double 22% LAD 39% C 7% RCA 38% Triple 13% Single 65% LCX 22%

  17. Lesion Characteristics ACC/AHA Classification calcification 12.4% (mod. - severe) thrombus 2.6% eccentric 44.9% angulation > 45o 4.1% C 7% A 20% B2 33% B1 40%

  18. QCA Data Before Procedure reference vessel diameter (RD) 2.94±.47 mm minimum lumen diameter (MLD) 1.05±.47 mm %-diameter stenosis 64±15 % lesion length 10.6±4.4 mm

  19. Procedural Characteristics device success* 100 % procedural success** 98.9 % # of stents deployed 1 89.9% 2 9.4 % 3 0.4 % ≥4 0.4 % stentedlength 17.2 6.3mm GP IIb/IIIa inhibitors53.6 % * < 50% residual stenosis of TS using treatment device **< 50% device success w/o death, emergent CABG, QMI or NQMI post-procedure, prior to hospital discharge

  20. Acute Angiographic Results in-stent MLD 2.88±.40 mm final %-diameter stenosis 4.9±9.2 % acute lumen gain 1.82±.52 mm dissection: type A 0.0 %type B 0.4 %type C 0.4 %

  21. Clinical Outcome at 30 Days

  22. Quantitative Angiographic Data at 180 Days* in-stent MLD 2.06±.65 mm in-stent %-diameter stenosis 29.219.2% late loss (in-stent) 0.830.56 mm loss index (in-stent) 0.420.02 *81% complete

  23. Binary Restenosis Rate at 180 Days* *81% complete

  24. Clinical Outcome at 180 Days TVR* due to ischemic symptoms or positive functional study

  25. David Cox‘ Summary • The multicellular design, reduced strut thickness (80µm) and novel CoCr alloy provide enhanced deliver-ability, scaffolding and visibility while maintaining a similar restenosis profile in comparison with the 1st generation thin strut (50µm) SS 316L Multi-Link stent • excellent procedural outcomes: device success 100%, procedure success 98.9%, stent marginal dissection 0.8% • excellent early and late clinical outcomes: TVF of 1.9% (30 days) and 6.7% (180 days) • favorable late (180 day) angiographic results: binary restenosis of 16.7%late loss 0.83 mm; loss index 0.42

  26. Steps of Innovation in the Multi-Link Family The Multi-Link VISION stent represents thenext step in stent design and continues the tradition of innovation in Multi-Link stents.

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