Gore has announced US Food and Drug Administration (FDA) approval of an expanded indication for the Gore Excluder conformable abdominal aortic aneurysm (AAA) endoprosthesis. The device is now indicated for patients with aortic neck angulation ≤90° and a minimum length of 10mm.
A company press release states that, with the expanded indication, the Gore Excluder conformable AAA device is now the only FDA-approved endovascular device solution indicated for patients with aortic neck angulation up to 90° and neck length of 10mm.
“This is a landmark indication for an EVAR [endovascular aneurysm repair] device, equipping physicians with an on-label solution for more patients with hostile neck anatomy,” said Robert Rhee, national principal investigator of the Gore Excluder conformable AAA endoprosthesis pivotal study and chief of vascular and endovascular surgery at Maimonides Medical Center (New York, USA).
There were 95 patients enrolled in the high neck angulation sub-study. Through one year, patients experienced a low incidence of type I endoleaks and zero type III endoleaks, zero reported aneurysm-related mortality, migrations, ruptures or stent fractures.
“We deliberately studied performance in both highly angulated and short necks, and the results demonstrate that we can safely and effectively treat these patients—providing an improved potential for favourable outcomes despite hostile anatomy,” Rhee added.
The press release continues that the Gore Excluder conformable AAA endoprosthesis with Active Control system—introduced in the USA in 2020—is the first AAA device to feature angulation control, empowering operators with two opportunities to achieve orthogonal placement in the aortic blood flow lumen. According to Gore, this unique degree of control, along with nesting stent rows and individual stent rings, helps maximise the conformability and seal of the device.
This latest announcement is “the culmination of years of deep collaboration with physicians to understand and overcome treatment challenges in highly angulated necks,” according to Gore Aortic business leader Willy Davison.
Moving forward, the Gore Excluder conformable AAA device will also be studied as part of the 10,000-patient Together registry, with up to 10-year follow-up and minimal inclusion and exclusion criteria to align with real-world clinical care practice. Uniquely, prospective imaging will also be collected for most patients.
