Gore | C3 EXCLUDER AAA Endoprosthesis

“Since completing the initial clinical trial, we have made one modification to the GORE EXCLUDER AAA Endoprosthesis design by adding a low-permeability film layer to the graft,” said Ryan Takeuchi, Aortic Business Unit Leader at Gore. “Requiring so few changes to the graft is unprecedented, yet we have strived to broaden the applicability and value to more patients by expanding the portfolio of sizes, reducing profile, and introducing an innovative, repositionable deployment system.”

The second-generation GORE®EXCLUDER® Device effectively addressed the endotensionproblem.

The GORE EXCLUDER Iliac Branch Device Clinical Study, a prospective, multicenter, non-randomized, single-arm study designed to assess the safety and effectiveness of the IBE in treating common iliac artery aneurysms or aortoiliac aneurysms, completed enrollment in February 2015. A total of 62 patients received the device, which met the FDA required enrollment of 60 patients. The trial also enrolled an additional 32 patients through Continued Access (as of February 15, 2016), which expanded treatment options to allow for bilateral placement of the IBE in addition to unilateral IBE device placement, which was evaluated in the Primary Enrollment.

Endoprotesis GORE EXCLUDER AAA de Gore Medical - …

Gore C3 EXCLUDER AAA Endoprosthesis - Independent Reviews by Clinicians for Clinicians

today announced receipt of CE Mark for the GORE® EXCLUDER® Conformable AAA Device, a product designed for the treatment of abdominal aortic aneurysms (AAA) in patients with challenging anatomies. This device is the latest addition in Gore’s growing portfolio of innovative solutions for the endovascular treatment of aortic disease. Leveraging Gore’s AAA device experience which has benefited more than 250,000 patients worldwide*, this new device builds upon a history unmatched by currently available stent-grafts.

Excluder iliac branch endoprosthesis receives the …

The clinical trial consists of two sub-studies, each assessing the device for a different range of patient anatomies. The first sub-study will assess the device in proximal aortic neck angles of zero to 60 degrees and aortic neck lengths of 10 mm or greater. The other sub-study will evaluate proximal aortic neck angles of 61 to 90 degrees and aortic neck lengths of 10 mm or greater. Once approved, the GORE EXCLUDER Conformable AAA Endoprosthesis would be the only device indicated for aortic neck angles up to 90 degrees and aortic neck lengths as short as 10 mm.

GORE EXCLUDER AAA Endoprosthesis’ lower profile …

“Extreme proximal neck anatomies are one of the main reasons why a AAA patient would not qualify for endovascular therapy,” said Dr. Ohki. “The new GORE EXCLUDER Conformable AAA Endoprosthesis will provide a minimally invasive treatment option for patients in this situation, some of whom are unfit for open surgery. For these patients, this device may be their only treatment option.”

The GORE EXCLUDER AAA Endoprosthesis is …

“Even if a device is flexible enough to accommodate a highly angulated aortic neck, achieving conformability during deployment with current delivery systems can be difficult,” said Dr. Rhee. “The GORE EXCLUDER Conformable Device delivery system is designed to give physicians a greater level of control over device placement to maximize device conformability regardless of anatomic challenges.”

FDA approval for new Gore Excluder AAA Endoprosthesis components

“FDA approval of this device is extremely important as it provides an iliac branch solution for a patient group with a previously unmet treatment need,” said Ryan Takeuchi, Gore Aortic Business Leader. “The GORE EXCLUDER Iliac Branch Device has demonstrated high patency, conformability, and durability and provides physicians with an on-label, minimally invasive method of preserving flow to the internal and external iliac arteries. Not only is IBE the first off-the-shelf aortic branch device approved in the United States, it is a part of a complete portfolio of aortic branch solutions that are currently in clinical evaluation.”