W.L. Gore & Associates said today it won CE Mark approval in the European Union for its Excluder conformable device designed to treat abdominal aortic aneurysms in patients with challenging anatomies.
The newly cleared Excluder device won approval for patients with either proximal aortic neck angles of up to 90 degrees or a minimum aortic neck length of 10 mm, the Newark, Del.-based company said.
“With the Gore Excluder Conformable Device, our EVAR solutions will offer the broadest treatment range of any supplier in the market. The feedback received on this new product suggests a high level of interest from physicians seeking to treat challenging AAA anatomies. As we scale up operations to meet this demand, we look forward to bringing this valuable product to patients and physicians,” aortic biz unit leader Ryan Takeuchi said in prepared remarks.
The device is designed with Gore’s active control system technology which allows operating physicians to angle the device to “optimize comformability and maximize seal in the proximal aortic neck,” Gore said.
“Before this approval, in order to qualify for EVAR, the patient had to fit a fairly narrow subset of anatomical criteria. The Gore Excluder Conformable AAA Endoprosthesis will expand the applicability of EVAR to patients traditionally considered to have anatomy too challenging for endovascular treatment,” Dr. Robert Rhee of New York’s Maimonides Medical Center said in a press release.
In April, Gore said it won Health Canada approval for its Excluder iliac branch endoprosthesis designed for the endovascular treatment of common iliac artery aneurysms or aortoiliac aneurysms.
In February, Gore said it won won FDA approval for its Excluder stent graft, making it the 1st company on the U.S. market with an off-the-shelf aortic branch device indicated for common iliac artery or aortoiliac aneurysms, the company said.