W. L. Gore & Associates (Gore) today announced the first use of the Food and Drug Administration (FDA)-approved Gore Excluder conformable abdominal aortic aneurysm (AAA) endoprothesis with Active Control system in cases outside of clinical trials. Cases were successfully performed by Robert Rhee, MD, with Mahmoud Almadani, MD, at Maimonides Medical Center in New York, and by Gustavo Oderich, MD, with Naveed Saqib, MD, at UTHealth in Houston.
The Gore Excluder conformable AAA endoprosthesis, which was approved by the FDA in December 2020, is a unique endovascular aneurysm repair (EVAR) solution which saw 100% technical success, 100% freedom from device related serious adverse events, and 100% patency in the first clinical trial sub-study. The study enrolled 80 patients who completed one-year follow-up and experienced zero type I or III endoleaks, migrations, ruptures, conversions to open repair, stent fractures, or limb occlusions. Enrollment in the high neck angulation sub-study is ongoing.
“The addition of the Gore Excluder conformable device to the Gore Excluder device family allows physicians to select the best device for their patient’s anatomy,” said Rhee, the national principal investigator. “Gore has combined a novel stent design, device conformability, and an enhanced delivery system to give physicians even more control when we need it most.”
According to Gore, this delivery system is the first to feature an optional angulation control, giving implanting surgeons the ability to angle or bend the device to achieve orthogonal placement to the aortic blood flow lumen, and to maximize the conformability and seal of the device.
“The Gore Excluder conformable device is another step forward in addressing areas of clinical need with a unique combination of conformability, precision, and repositioning capabilities,” said Oderich.
Gore is committed to the ongoing evaluation of the device performance and seeking potential expansion of approved indications based on data that continues to be collected from the remaining arm of the clinical study.