Gore Launches Excluder Conformable AAA Endoprosthesis With Active Control System

March 30, 2021—Gore & Associates, Inc. announced the first use of the FDA-approved Excluder conformable abdominal aortic aneurysm (AAA) endoprosthesis with Active Control system in cases outside of clinical trials.

According to the company, the device features a conformable stent graft, enhanced device positioning, and optional angulation control. The delivery system’s angulation control gives interventionalists the option to angle the device to achieve orthogonal placement to the aortic blood flow lumen to maximize conformability and seal.

In January, Gore announced that the device was approved by the FDA. FDA approval was supported by findings from a clinical trial assessing the device in the treatment of AAA.

In a substudy of the trial, the Excluder device demonstrated 100% technical success, 100% freedom from device-related serious adverse events, and 100% patency. The study was composed of 80 patients who completed 1-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 substudy is ongoing.

Gore advised that it is committed to the ongoing evaluation of the device performance and is seeking potential expansion of approved indications based on data that continue to be collected from the remaining arm of the clinical study.

The first commercial cases were performed by Robert Rhee, MD, with Mahmoud Almadani, MD, and by Gustavo Oderich, MD, with Naveed Saqib, MD.

Dr. Rhee, who is Chief of Vascular and Endovascular Surgery at Maimonides Medical Center in Brooklyn, New York, serves as National Principal Investigator of the study.

“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,” commented Dr. Rhee in the company’s press release. “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.”

Dr. Oderich added, “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.” Dr. Oderich is Professor and Chief of Vascular and Endovascular Surgery at McGovern Medical School at UTHealth in Houston, Texas.