GORE VIABAHN Endoprosthesis GORE VIABAHN and designs are
GORE® VIABAHN® Endoprosthesis GORE, VIABAHN ®, and designs are trademarks of W. L. Gore & Associates. © 2009 W. L. Gore & Associates, Inc. GORE®, PROPATEN, VIABAHN ®, and designs are trademarks of W. L. Gore & Associates. © 2009, 2010 W. L. Gore & Associates, Inc.
Produto Contorno na borda proximal e. PTFE PROPATEN (heparina) Film Nitinol Comprimentos: 2. 5, 5, 10, 15, 25 cm Diâmetros: 5 – 13 mm GORE®, PROPATEN, and designs are trademarks of W. L. Gore & Associates. © 2009, 2010 W. L. Gore & Associates, Inc.
SFA Individual results may vary. GORE®, VIABAHN®, and designs are trademarks of W. L. Gore & Associates. © 2009, 2010 W. L. Gore & Associates, Inc.
Características e Benefícios • Stent de nitinol • Baixo perfil • Superfície com heparina • Contorno da borda proximal • Sistema de liberação • 25 cm de comprimento – Conformavel e flexível – Permite o tratamento de lesões complexas – Resistência na formação de trombos – Diminuição da reestenose de borda – Compatível com guia 0. 035” – Liberação TIP to HUB – Expansão radial – Possibilidade de tratar uma lesão com somente um device – Reduz a necessidade de overlapping GORE® and designs are trademarks of W. L. Gore & Associates. © 2009, 2010 W. L. Gore & Associates, Inc.
Evolução GORE®, HEMOBAHN®, TIP to HUB, PROPATEN, VIABAHN ®, and designs are trademarks of W. L. Gore & Associates. © 2009, 2010 W. L. Gore & Associates, Inc.
GORE® VIABAHN® Endoprosthesis: Novo contorno GORE®, VIABAHN®, and designs are trademarks of W. L. Gore & Associates. © 2009, 2010 W. L. Gore & Associates, Inc.
Contorno: Modelo canino 90 day 30 day IVUS demonstra a perfeita aposição ao vaso GORE® and designs are trademarks of W. L. Gore & Associates. © 2009, 2010 W. L. Gore & Associates, Inc.
Comparativo GORE®, HEMOBAHN®, HUB to TIP, PROPATEN, TIP to HUB, VIABAHN ®, and designs are trademarks of W. L. Gore & Associates. © 2009, 2010 W. L. Gore & Associates, Inc. AVANTI® is a registered trademark of Cordis Corporation. INTRADYN is a registered trademark of B. Braun Medical, Inc. SUPER SHEATH is a registered trademark of Boston Scientific Corporation.
Comparativo GORE®, HEMOBAHN®, HUB to TIP, PROPATEN, TIP to HUB, VIABAHN ®, and designs are trademarks of W. L. Gore & Associates. © 2009, 2010 W. L. Gore & Associates, Inc. AVANTI® is a registered trademark of Cordis Corporation. INTRADYN is a registered trademark of B. Braun Medical, Inc. SUPER SHEATH is a registered trademark of Boston Scientific Corporation.
Configurações GORE®, TIP to HUB logo, and designs are trademarks of W. L. Gore & Associates. © 2009, 2010 W. L. Gore & Associates, Inc.
Configurações GORE®, TIP to HUB logo, and designs are trademarks of W. L. Gore & Associates. © 2009, 2010 W. L. Gore & Associates, Inc.
Configurações GORE®, TIP to HUB logo, and designs are trademarks of W. L. Gore & Associates. © 2009, 2010 W. L. Gore & Associates, Inc. AVANTI® is a registered trademark of Cordis Corporation. INTRADYN is a registered trademark of B. Braun Medical, Inc. SUPER SHEATH is a registered trademark of Boston Scientific Corporation.
TIP to HUB 0. 035" guidewire Guidewire Access 1. Cruze a lesão com o fio guia. Device Deployment 4. Comece a liberação. Balloon Dilatation 2. Pré-dilatação. Balloon Touch-up 5. Indicamos realizar uma pósdilatação touch-up. GORE®, TIP to HUB, and designs are trademarks of W. L. Gore & Associates. © 2009, 2010 W. L. Gore & Associates, Inc. Device Location 3. Confirme o posicionamento correto para o início da liberação. Device Location 6. A parte proximal deve cobrir o vaso 1 cm para estenose 2 cm para aneurisma
Dicas • Evitar lesões não-complacentes • Assegure inflow e outflow (no mínimo um vaso com run-off) • Escolher o diâmetro adequado • Nas estenoses o Viabahn deve cobrir 1 cm distal e 1 cm proximal do vaso e 2 cm no tratamento da doença aneurismática • Colocar o Viabahn em toda a parte do vaso que foi dilatada com o balão • A pós-dilatação só precisa ser realizada na região que está com o Viabahn • Manter medicação antiplaquetária pós procedimento GORE® and designs are trademarks of W. L. Gore & Associates. © 2009, 2010 W. L. Gore & Associates, Inc.
Estudos Clínicos GORE, VIABAHN ®, and designs are trademarks of W. L. Gore & Associates. © 2009 W. L. Gore & Associates, Inc. GORE® and designs are trademarks of W. L. Gore & Associates. © 2009, 2010 W. L. Gore & Associates, Inc.
Primary patency of GORE® VIABAHN® Endoprosthesis in the SFA* GORE®, HEMOBAHN®, VIABAHN®, and designs are trademarks of W. L. Gore & Associates. © 2009, 2010 W. L. Gore & Associates, Inc.
Estudo Baylor Prospectivo, randomizado - comparação do GORE® VIABAHN® versus bypass femoro-poplíteo no tratamento da doença olcusiva na artéria femoral superficial Mc. Quade K, Gable DR, Pearl GJ, Theune B. Four-year randomized prospective comparison of percutaneous expanded polytetrafluoroethylene/nitinol self-expanding stent graft vs prosthetic femoral-popliteal bypass in the treatment of superficial femoral artery occlusive disease. Abstract presented at the Southern Association for Vascular Surgery (SAVS) 34 th Annual Meeting; January 20 -23, 2010; Paradise Island, Bahamas. Journal of Vascular Surgery 2009; 50(6): 1531. GORE®, VIABAHN®, and designs are trademarks of W. L. Gore & Associates. © 2009, 2010 W. L. Gore & Associates, Inc. ® is a trademark of Invista, Inc. , and is licensed to Unifi Inc. . DACRON
Saxon: follow-up em 4 anos Não randomizado, centro único investigando patencia of GORE® VIABAHN® Endoprosthesis em lesões de comprimento intermediário com 04 anos de follow-up Saxon RR, Coffman JM, Gooding JM, Ponec DJ. Long-term Patency and Clinical Outcome of the Viabahn Stent-Grafts for Femoropopliteal Artery Obstructions. Abstract presented at the SIR 31 st Annual Scientific Meeting. Journal of Vascular & Interventional Radiology 2007; 18: 1341 -1350. GORE®, VIABAHN®, and designs are trademarks of W. L. Gore & Associates. © 2009, 2010 W. L. Gore & Associates, Inc.
GORE® VIABAHN® Endoprosthesis Com superfície bioativa PROPATEN GORE, VIABAHN ®, and designs are trademarks of W. L. Gore & Associates. © 2009 W. L. Gore & Associates, Inc. GORE®, PROPATEN, VIABAHN ®, and designs are trademarks of W. L. Gore & Associates. © 2009, 2010 W. L. Gore & Associates, Inc.
Tecnologia única • As moléculas de heparina estão na superfície da endoprótese – Heparina é um polissacarídeo anticoagulante com longa história em uso clínico. 1 – Heparina possui um efeito antiproliferativo nas células musculares lisas. 2 • Gore possui um mecanismo que permite a retenção da bioatividade (CARMEDA® Bio. Active Surface Technology (CBAS®) • Tromboresistência 1 Hirsh J, Anand SS, Halperin JL, Fuster V. AHA Scientific statement. Guide to anticoagulant therapy: heparin. Circulation 2001; 103: 2994 -3018. AW, Karnowsky MJ. Suppression by heparin of smooth muscle cell proliferation in injured arteries. Nature 1977; 265: 625 -6. 2 Clowes GORE® and designs are trademarks of W. L. Gore & Associates. © 2009, 2010 W. L. Gore & Associates, Inc. CARMEDA® and CBAS ® are trademarks of Carmeda AB, a wholly owned subsidiary of W. L. Gore & Associates.
Tecnologia única e. PTFE Molécula de heparina Site bioativo da heparina GORE® and designs are trademarks of W. L. Gore & Associates. © 2009, 2010 W. L. Gore & Associates, Inc.
Mecanismo de ação • • • A molécula de heparina é ligada ao pfte por uma ligação covalente O site bioativo possui afinidade com a molécula antitrombina (AT) A Antitrombin (AT) se liga a trombina (T) – formando um complexo neutro AT-T Trombina perde a capacidade em catalisar a conversão do fibrinogênio em fibrina O complexo neutro AT-T se solta da molécula de heparina O site fica bioativo novamente GORE® and designs are trademarks of W. L. Gore & Associates. © 2009, 2010 W. L. Gore & Associates, Inc.
Tromboresistente GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface Control Endoprosthesis Superfície 5 mm de diâmetro GORE® VIABAHN® Endoprosthesis com Propaten livre de trombo após duas horas em um modelo in vitro. O controle apresenta a presença de trombo (sem terapia anticoagulante). GORE®, PROPATEN, VIABAHN ®, and designs are trademarks of W. L. Gore & Associates. © 2009, 2010 W. L. Gore & Associates, Inc.
Bioatividade *Begovac PC, Thomson RC, Fisher JL, Hughson A, Gällhagen A. Improvements in GORE-TEX® Vascular Graft performance by Carmeda® bioactive surface heparin immobilization. European Journal of Vascular and Endovascular Surgery 2003; 25(5): 432 -437. GORE®, GORE-TEX®, and designs are trademarks of W. L. Gore & Associates. © 2009, 2010 W. L. Gore & Associates, Inc. CARMEDA® is a trademark of Carmeda AB, a wholly owned subsidiary of W. L. Gore & Associates.
GORE® VIABAHN® with PROPATEN Bioactive Surface: First Data • • 50 membros 85 Viabahn No evidence of HIT 0% trombose em 6 meses Chadda N, Museitif R, Djelmami-Hani M, et al. Heparin-Bonded VIABAHN Stent Graft for SFA Lesions: incidence of stent thrombosis and heparin-induced thrombocytopenia. Abstract presented at the TCT 2008: Transcatheter Cardiovascular Therapeutics 20 th Annual Scientific Symposium; October 12 -17, 2008; Washington, DC. American Journal of Cardiology 2008; 102(8)Supplement 1: 221 i. GORE®, PROPATEN, VIABAHN ®, and designs are trademarks of W. L. Gore & Associates. © 2009, 2010 W. L. Gore & Associates, Inc.
Estudos clínicos GORE, VIABAHN ®, and designs are trademarks of W. L. Gore & Associates. © 2009 W. L. Gore & Associates, Inc. GORE® and designs are trademarks of W. L. Gore & Associates. © 2009, 2010 W. L. Gore & Associates, Inc.
Gore VIPER Clinical Study GORE®, PROPATEN, VIABAHN ®, and designs are trademarks of W. L. Gore & Associates. © 2009, 2010 W. L. Gore & Associates, Inc.
Sizing to Optimize Outcomes – In the Gore VIPER Clinical Study, primary patency was 91% when devices were sized according to the IFU (≤ 20% oversizing) a significant improvement over devices sized > 20% (p < 0. 05)
VIASTAR Clinical Study GORE® and designs are trademarks of W. L. Gore & Associates. © 2009, 2010 W. L. Gore & Associates, Inc.
213 Viabahns 20 endoleak Only 3 still present at the follow up 4 occlusions
This piece is intended for OUS distribution. Products listed may not be available in all markets. GORE®, GORE-TEX®, HEMOBAHN®, HUB to TIP, PROPATEN, TIP to HUB logo, VIABAHN®, and designs are trademarks of W. L. Gore & Associates. © 2009, 2010 W. L. Gore & Associates, Inc. AL 0752 -EU 4 MARCH 2010
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