W L Gore & Associates (Gore) has secured the CE Mark for its Gore Excluder Conformable AAA Device to treat abdominal aortic aneurysms (AAA).
The device can be used for patients with a challenging anatomy, it has been approved for patients with proximal aortic neck angles of up to 90 degrees or a minimum aortic neck length of 10mm.
AAA is an enlarged area in the lower part of the aorta, which is the major blood vessel supplying blood to the body.
The design of the new device is similar to that of Gore’s Conformable Gore Tag Device. It is based on Gore’s Active Control System, which allows the physicians to angle the device in order to facilitate an optimised conformability and a pronounced sealing of the proximal aortic neck.
Maimonides Medical Center Vascular and Endovascular Surgery chief Robert Rhee said: "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."
The device has now been added to Gore’s existing portfolio of solutions for the endovascular treatment of aortic disease which includes the Gore Excluder Iliac Branch Endoprosthesis (IBE) for endovascular treatment of common iliac artery aneurysms or aortoiliac aneurysms.
The company is undertaking studies in the US for the Gore Excluder Thoracoabdominal Device and the Gore Tag Thoracic Branch Device.
Image: A rendering of the Gore Excluder Conformable AAA Device. Photo: courtesy of Business Wire.