W. L. Gore & Associates, Inc. (Gore) has received FDA approval 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.
“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 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. 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.
“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 Aortic Business Leader. “Gore is committed to providing physicians with innovative solutions that improve patient outcomes.”
The GORE EXCLUDER AAA Endoprosthesis is the result of collaboration between leading endovascular aneurysm repair (EVAR) physicians and Gore engineers. With more than 135,000 devices distributed worldwide, the GORE EXCLUDER AAA Endoprosthesis is characterized by its low profile, flexible on and off catheter characteristics, active infrarenal fixation and strong clinical data. In addition, the GORE EXCLUDER Device is supported by a highly rated clinical support team, a comprehensive educational offering, and Gore’s outstanding community awareness programs.