Gore Gets FDA OK for Expanded Sizes of AAA Treatment Device

The Medical division of W. L. Gore & Associates, Inc. has received approval from the U.S. Food and Drug Administration 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 new diameter devices provide physicians with the ability to repair AAAs in a wider range of anatomies eligible for minimally invasive endovascular AAA repair, according to the company.

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

The 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. Once the physician has positioned the graft in the diseased aorta, the Gore’s C3 Delivery System is used to reposition 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.

“The availability of new diameter … device components expands the use of this device to a wider range of anatomical considerations,” said David Abeyta, head of Gore’s aortic business unit. “Gore is committed to providing physicians with innovative solutions that improve patient outcomes.”

According to the company the device’s development is the result of is the result of collaboration between leading EVAR physicians and Gore engineers.

Gore Medical is based in Flagstaff, Ariz.