CE Mark For New GORE® EXCLUDER® AAA Endoprosthesis Sizing Options

In short

W. L. Gore & Associates, Inc. has received CE mark for the 23 mm and 27 mm diameter sizes of the contralateral leg component of the Gore® Excluder® AAA Endoprosthesis for treatment of abdominal aortic aneurysm (AAA). The company says its new diameter devices provide physicians with the ability to repair AAAs in a wider range of anatomies eligible for minimally invasive endovascular AAA repair.

Background

The Gore Excluder AAA Endoprosthesis is an endovascular stent-graft that seals off the aneurysm and creates a new path for blood flow. The device is inserted through a small incision in the patient’s leg using a catheter-based delivery technique.

We last covered Gore’s Excluder endoprosthesis as far back as 2009, here, when the company announced the launch of its 31mm size derivative. The product, originally CE marked and launched in Europe as far back as 2004 has been quite a success story with more than 135,000 devices distributed worldwide.

Now the company is announcing the CE mark approval for two new contralateral leg sizes which it claims will simplify endovascular aneurysm repair in a new cohort of patients, those with larger iliac arteries.

Once the physician has positioned the graft in the diseased aorta, the Gore C3 Delivery System uniquely and intuitively enables repositioning of the stent-graft. The ability to reposition the device may minimize complications that could occur if the graft needs to be moved after the initial deployment.

Company comments

“By adding new diameter options to the GORE EXCLUDER Device, patients with large iliac arteries can now be treated with fewer components. This will simplify the EVAR procedure for these patients, widen its applicability, and reduce its costs,” said Dr. Michel Makaroun, MD, Professor and Chair, Division of Vascular Surgery, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.

“The availability of new diameter GORE EXCLUDER Device components expands the use of this device to a wider range of anatomical considerations,” said David Abeyta, Gore Business Leader. “Gore is committed to providing physicians with innovative solutions that improve patient outcomes.”

Source: W.L.Gore & Associates Inc., Business Wire