GORE’s EXCLUDER Conformable AAA Endoprosthesis Approved for Expanded Indication
W. L. Gore & Associates (Gore) announces FDA approval of an expanded indication for the GORE® EXCLUDER® Conformable AAA Endoprosthesis. The endovascular aneurysm repair (EVAR) device is now indicated for patients with highly angulated necks, specifically aortic neck angulation ≤ 90° and a minimum length of 10 mm.
The GORE® EXCLUDER® Conformable AAA Endoprosthesis with Active Control System was FDA-approved in 2021, offering a conformable stent graft; enhanced device positioning; and optional angulation control. This allows physicians to optimize graft conformability and seal to the vessel.
According to GORE, there were 95 patients enrolled in the high neck angulation sub-study. Throughout the first year, patients experienced a low incidence of Type I endoleaks, and no Type III endoleaks. In addition, there were no reported aneurysm-related mortalities, migrations, ruptures or stent fractures.
“This is a landmark indication for an EVAR device, equipping physicians with an on-label solution for more patients with hostile neck anatomy,” commented Robert Rhee, MD, in the company’s press release. Dr. Rhee served as national Principal Investigator of the pivotal study that assessed the Excluder conformable AAA endoprosthesis.
