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Health Canada Approves Gore Excluder Iliac Branch Endoprosthesis.

M2 PHARMA-April 21, 2016-Health Canada Approves Gore Excluder Iliac Branch Endoprosthesis


- Health Canada has approved US-based medical device company W. L. Gore and Associates, Inc. the Gore Excluder Iliac Branch Endoprosthesis, the company said.

Gore said that the approval makes the device the most recent off-the-shelf aortic branch device approved in Canada for the endovascular treatment of common iliac artery aneurysms or aortoiliac aneurysms.

With more than 1,000 commercial implants worldwide, the device received CE Mark in 2013, registered in Australia and New Zealand in 2015, and FDA approved in February of this year.

Used in conjunction with the Gore Excluder AAA Endoprosthesis, the IBE preserves blood flow in the external iliac and internal iliac arteries.

The IBE leverages the design and experience acquired from more than 18 years and 250,000 patients treated with the Gore Excluder Device and utilises the same durable, expanded polytetrafluoroethylene (ePTFE) graft and nitinol stent material.

The IBE All-in-One System advances repair with proven outcomes for the treatment of iliac artery aneurysms.

As the recommended treatment of vascular surgery societies, the preservation of blood flow in the internal iliac arteries can avoid pelvic flow disruption and reduce the rate of buttock claudication, sexual dysfunction, and colonic ischemia.

In the United States clinical trial, there have been no reports of buttock claudication on the IBE treatment side and no reports of new-onset sexual dysfunction through six-months follow-up.

The IBE system provides a treatment range of 6.5-13.5 mm for the internal iliac arteries, and a treatment range of 6.5-25 mm for the external iliac arteries.

Gore said that the delivery profile of the loaded catheter allows the use of a 16 Fr introducer sheath for the iliac branch component, and a flexible 12 Fr, reinforced introducer sheath for the internal iliac component.

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Publication:M2 Pharma
Geographic Code:1CANA
Date:Apr 21, 2016
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