FDA Approves Gore Excluder Conformable AAA Endoprosthesis with Active Control System

January 19, 2021—Gore & Associates recently announced FDA approval for the Excluder conformable abdominal aortic aneurysm (AAA) endoprosthesis with Active Control system for endovascular aneurysm repair (EVAR). The device builds on the company’s Excluder AAA device and incorporates design elements similar to the TAG conformable thoracic stent graft.

The new device, which introduces the company’s Active Control system into treatment of AAA, features a conformable stent graft, enhanced device positioning, and optional angulation control. The delivery system’s angulation control gives physicians the option to angle the device to achieve orthogonal placement to the aortic blood flow lumen to maximize conformability and seal.

“I am impressed with how well the device performed in the clinical study and appreciate the efforts of the investigators who contributed to this milestone,” commented Robert Rhee, MD, Chief of Vascular and Endovascular Surgery at Maimonides Medical Center in Brooklyn, New York. Dr. Rhee, who is National Principal Investigator of the trial assessing the Gore Excluder conformable AAA device, continued, “The data submitted to the FDA included 100% technical success, 100% freedom from device-related serious adverse events, and 100% patency.”

The data referenced by Dr. Rhee are from the first substudy of the clinical trial, which enrolled 80 patients who completed 1-year follow-up. The second substudy of the trial will evaluate the device in proximal aortic neck angles of > 60º to 90º and aortic neck lengths of ≥ 10 mm. Enrollment in this substudy is ongoing.

Dr. Rhee continued, “Additionally, there were no type I/III endoleaks, migration, rupture, conversion to open repair, stent fractures, or limb occlusions, and 98.6% of patients showed freedom from aneurysm enlargement. I am confident this device will expand EVAR treatment options for patients diagnosed with AAAs.”

The Gore Excluder conformable AAA endoprosthesis with Active Control system received European CE Mark approval in 2016, noted the company.