NEW DESIGN FOR S.F.A STENT : Dual Component
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1 NEW DESIGN FOR S.F.A STENT : Dual Component 1 Max Amor Louis MAX Pasteur AMOR Clinic Above-Knee Essey and les Below-Knee Nancy Data France
2 Dual Component Stent Design Designed to: Maximize flexibility while minimizing risk of stent fracture Allow axial compression while resisting stent elongation Conforms and allows vessel movement
3 Gore Solution: Dual Component Stent Design CARMEDA and CBAS are trademarks of Carmeda AB, a wholly owned subsidiary of W. L. Gore & Associates, Inc. GORE and designs are trademarks of W. L. Gore & Associates W. L. Gore & Associates, Inc.
4 Fluoropolymer Enables Axial Compressibility GORE and designs are trademarks of W. L. Gore & Associates W. L. Gore & Associates, Inc.
5 Progression of Evaluation Bench-top Testing Pre-Clinical In Vivo Testing Limited Release Clinical Evaluation
6 Elongation Testing Test 6 mm x 80 mm stents Clamp with 70 mm exposed Apply 70 grams force Measure elongation Significance Less elongation provides deployment accuracy and may decreased potential for stent fracture GORE and designs are trademarks of W. L. Gore & Associates W. L. Gore & Associates, Inc.
7 Elongation Results LifeStent, and LUMINEXX, are trademarks and / or registered trademarks of C. R. Bard, Inc. S.M.A.R.T. and CONTROL are trademarks of Cordis Corporation. Protégé and EverFlex are trademarks of Covidien. ABSOLUTE is a trademark of Abbott Laboratories. sinus-superflex is a trademark of OptiMed. ZILVER and PTX are trademarks of COOK Medical. SUPERA is a trademark of IDEV. GORE, TIGRIS, and designs are trademarks of W. L. Gore & Associates W. L. Gore & Associates, Inc.
8 Impact of Elongation LifeStent is a trademark and / or registered trademarks of C. R. Bard, Inc. GORE, TIGRIS, and designs are trademarks of W. L. Gore & Associates W. L. Gore & Associates, Inc.
9 Straightening Force Testing Test 6 mm x 80 mm stents Clamp one end of the stent Displace the free end 15 mm down Measure upward force of stent Significance Less straightening force allows the stent to conform to vessel movement GORE and designs are trademarks of W. L. Gore & Associates W. L. Gore & Associates, Inc.
10 Straightening Force Results LifeStent, and LUMINEXX, are trademarks and / or registered trademarks of C. R. Bard, Inc. S.M.A.R.T. and CONTROL are trademarks of Cordis Corporation. Protégé and EverFlex are trademarks of Covidien. ABSOLUTE is a trademark of Abbott Laboratories. sinus-superflex is a trademark of OptiMed. ZILVER and PTX are trademarks of COOK Medical. SUPERA is a trademark of IDEV. GORE, TIGRIS, and designs are trademarks of W. L. Gore & Associates W. L. Gore & Associates, Inc.
11 Flexibility Testing GORE TIGRIS Vascular Stent BARD LifeStent Vascular Stent IDEV SUPERA Stent Cordis S.M.A.R.T. CONTROL Stent Covidien Protege EverFlex Stent LifeStent are trademarks and / or registered trademarks of C. R. Bard, Inc. S.M.A.R.T. and CONTROL are trademarks of Cordis Corporation. Protégé are trademarks of Covidien. SUPERA is a trademark of IDEV. GORE, TIGRIS, and designs are trademarks of W. L. Gore & Associates W. L. Gore & Associates, Inc.
12 Flexibility Testing (continued) Cook Zilver PTX Stent OptiMed sinus-superflex Stent Bard Lumminex Stent LUMINEXX, are trademarks and / or registered trademarks of C. R. Bard, Inc. sinus-superflex is a trademark of OptiMed. ZILVER and PTX are trademarks of COOK Medical.
13 Flexibility Testing (continued) GORE TIGRIS Vascular Stent Bard Lumminex Stent LUMINEXX is a trademark and / or registered trademarks of C. R. Bard, Inc. GORE, TIGRIS, and designs are trademarks of W. L. Gore & Associates W. L. Gore & Associates, Inc.
14 Longitudinal Compression Test 6 mm x 80 mm stents Compress 12 mm (15%) Measure force of stent resisting compression Significance Less resistance to compression allows the stent to naturally conform to vessel shortening and decreases potential for stent fracture GORE and designs are trademarks of W. L. Gore & Associates W. L. Gore & Associates, Inc.
15 Longitudinal Compression Testing Results LifeStent, and LUMINEXX, are trademarks and / or registered trademarks of C. R. Bard, Inc. S.M.A.R.T. and CONTROL are trademarks of Cordis Corporation. Protégé and EverFlex are trademarks of Covidien. ABSOLUTE is a trademark of Abbott Laboratories. sinus-superflex is a trademark of OptiMed. ZILVER and PTX are trademarks of COOK Medical. SUPERA is a trademark of IDEV. GORE,TIGRIS, and designs are trademarks of W. L. Gore & Associates W. L. Gore & Associates, Inc.
16 Longitudinal Compression Testing GORE TIGRIS Vascular Stent Cordis S.M.A.R.T. CONTROL Stent BARD LifeStent Vascular Stent Covidien Protege EverFlex Stent LifeStent are trademarks and / or registered trademarks of C. R. Bard, Inc. S.M.A.R.T. and CONTROL are trademarks of Cordis Corporation. Protégé and EverFlex are trademarks of Covidien. GORE,TIGRIS, and designs are trademarks of W. L. Gore & Associates W. L. Gore & Associates, Inc.
17 Blood Loop Test Test 6 mm x 80 mm stents Deploy in 5 mm tubing Circulate human blood at 37 C for two hours Significance Less thrombus formation maximizes potential for clinical patency GORE and designs are trademarks of W. L. Gore & Associates W. L. Gore & Associates, Inc.
18 Blood Loop Testing GORE TIGRIS Vascular Stent Covidien Protege EverFlex Stent IDEV SUPERA Stent Bard Lumminex Stent Abbott Absolute Pro LL Stent BARD LifeStent Vascular Stent LifeStent, and LUMINEXX, are trademarks and / or registered trademarks of C. R. Bard, Inc. Protégé and EverFlex are trademarks of Covidien. ABSOLUTE is a trademark of Abbott Laboratories. SUPERA is a trademark of IDEV. GORE,TIGRIS, and designs are trademarks of W. L. Gore & Associates W. L. Gore & Associates, Inc.
19 Blood Loop Testing (continued) OptiMed sinus-superflex Stent Cordis S.M.A.R.T. CONTROL Stent Cook Zilver PTX Stent S.M.A.R.T. and CONTROL are trademarks of Cordis Corporation. sinus-superflex is a trademark of OptiMed. ZILVER and PTX are trademarks of COOK Medical. GORE and designs are trademarks of W. L. Gore & Associates W. L. Gore & Associates, Inc.
20 Chronic In Vivo: 90 day histology Lumen surface of overlapped section is widely patent with a thin endothelialized neointima. Neointimal consists entirely of organized, fibromuscular neointima. Virtually no inflammatory cells present. GORE and designs are trademarks of W. L. Gore & Associates W. L. Gore & Associates, Inc.
21 First in Man Cases Park Krankenhaus, Leipzig, Germany Mid SFA Lesion 7 x 40 GORE TIGRIS Vascular Stent Popliteal Lesion 6 x 80 GORE TIGRIS Vascular Stent GORE,TIGRIS, and designs are trademarks of W. L. Gore & Associates W. L. Gore & Associates, Inc.
22 Conclusion The GORE TIGRIS Vascular Stent dual component design provides the unique combination of: Minimal stent elongation Low straightening force The ability to absorb longitudinal compression It mimics vessel movement and minimizes potential for stent fractures GORE,TIGRIS, and designs are trademarks of W. L. Gore & Associates W. L. Gore & Associates, Inc.
23
24 Images GORE and designs are trademarks of W. L. Gore & Associates W. L. Gore & Associates, Inc.
25 Images GORE and designs are trademarks of W. L. Gore & Associates W. L. Gore & Associates, Inc.
26 Images GORE and designs are trademarks of W. L. Gore & Associates W. L. Gore & Associates, Inc.
27 Images GORE and designs are trademarks of W. L. Gore & Associates W. L. Gore & Associates, Inc.
28 GORE, TIGRIS, VIABAHN, and designs are trademarks of W. L. Gore & Associates W. L. Gore & Associates, Inc. AR0149-EU1 APRIL 2012
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