GORE VIABAHN VBX Balloon Expandable Endoprosthesis -Peripheral artery endovascular stent-graft, drug-coated

国家: 澳大利亚

语言: 英文

来源: Department of Health (Therapeutic Goods Administration)

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26-05-2019

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W L Gore & Associates (Australia) Pty Ltd

类:

Class III

厂商:

WL Gore & Associates Inc 1505 North Fourth Street, Flagstaff, AZ, 86004 United States Of America

治疗领域:

66619 - Peripheral artery endovascular stent-graft, drug-coated

疗效迹象:

A balloon-expandable, endoluminal endoprosthesis consisting of a 316L surgical grade stainless steel stent and an ePTFE and FEP graft. Its surface is coated with an immobilized heparin surface (CBAS? Heparin Surface) which consists of CBAS? covalently attached to a polymeric base matrix consisting of polyethyleneimine (CBAS?-polymin) and dextran sulphate. The stent is pre-mounted on a delivery system equipped with a semi-compliant balloon. The GORE? VIABAHN? VBX Balloon Expandable Endoprosthesis is indicated for the treatment of de novo or restenotic lesions found in iliac arteries with reference vessel diameters ranging from 5 mm - 13 mm and lesion lengths up to 110 mm, including lesions at the aortic bifurcation.

授权状态:

A

授权日期:

2018-11-13

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