CE Mark Approval for Gore Excluder Conformable AAA Endoprosthesis

June 2, 2016—Gore & Associates announced European CE Mark approval for its Excluder conformable abdominal aortic aneurysm (AAA) device for the endovascular aneurysm repair (EVAR) of AAA in patients with challenging anatomies. The device is approved for patients with either proximal aortic neck angles of up to 90º or a minimum aortic neck length of 10 mm, as well as in patients with proximal aortic neck angles of up to 60º with a minimum aortic neck length of 10 mm.

According to the company, the Excluder conformable AAA device allows for tailored and precise treatment in more difficult anatomies. The device provides the repositionability, durability, and patency of the Excluder AAA device and incorporates stent design elements similar to its conformable TAG thoracic endoprosthesis to enable apposition in tortuous aortas. Additionally, the device introduces Gore’s Active Control System, which allows physicians to angle the device to optimize conformability and maximize seal in the proximal aortic neck.

In the company’s announcement, Robert Rhee, MD, commented, “Before this approval, in order to qualify for EVAR, the patient had to fit a fairly narrow subset of anatomical criteria. The Gore Excluder conformable AAA endoprosthesis will expand the applicability of EVAR to patients traditionally considered to have anatomy too challenging for endovascular treatment.” Dr. Rhee is Chief of Vascular and Endovascular Surgery at Maimonides Medical Center in New York, New York.

In June 2015, Gore announced approval for a clinical study in the United States and Japan to assess the safety and effectiveness of the Excluder conformable AAA endoprosthesis in treating infrarenal AAAs with challenging patient anatomy. Takao Ohki, MD, will be the Principal Investigator for Japan, and Dr. Rhee will be the Principal Investigator for the United States.