GORE® EXCLUDER® AAA Endoprosthesis Gore Completes Primary Enrollment for the Gore EXCLUDER® Iliac Branch Clinical Study

62 patients enrolled in US investigational device exemption clinical study to assess first complete, low-profile system for managing common iliac artery aneurysms or aorto-iliac aneurysms

Flagstaff, Ariz. (February 17, 2015)—W. L. Gore & Associates, Inc. (Gore) today announced that it has completed primary enrollment in the Gore EXCLUDER Iliac Branch Clinical Study, a prospective, multi-center, non-randomized, single-arm study designed to assess the safety and effectiveness of the GORE® EXCLUDER® Iliac Branch Endoprosthesis in treating common iliac artery aneurysms or aorto-iliac aneurysms.

A total of 62 patients have received the device, which completed the required enrollment of 60 set by the Food and Drug administration (FDA). Additionally, the FDA approved a Continued Access Protocol (CAP) allowing an additional 140 patients to be treated with the device. The CAP also includes use of the GORE EXCLUDER Iliac Branch Endoprosthesis for bilateral placement.

“An estimated 20 to 40 percent of patients with abdominal aortic aneurysms have common iliac arteries that also require repair, yet no device has been approved for this treatment indication in the United States,” said Darren Schneider, MD, chief of vascular and endovascular surgery at the Weill Cornell Medical College and principal investigator for the national trial. “This iliac branch device provides a wider range of patients with access to minimally invasive, endovascular treatment options.”

The GORE EXCLUDER Iliac Branch Device (iliac branch component and internal iliac component) is used in conjunction with the GORE® EXCLUDER® AAA Endoprosthesis to isolate the common iliac artery from systemic blood flow and preserve blood flow in the external iliac and internal iliac arteries.

“Completing primary enrollment marks a significant step toward achieving FDA approval for the GORE EXCLUDER Iliac Branch Device,” said Ryan Takeuchi, Aortic Business Unit Leader at Gore. “If approved, the iliac branch endoprosthesis would become the first and only device indicated to treat common iliac aneurysms in the United States.

In October 2013, the GORE EXCLUDER Iliac Branch Endoprosthesis became the first complete, fully engineered system (Gore designed iliac branch and internal iliac components) for treating common iliac artery aneurysms to receive Europe’s CE Mark.

Gore has achieved several other key milestones in its commitment to providing the most complete portfolio of products intended to durably treat the aorta. The GORE® TAG® Thoracic Branch Endoprosthesis received FDA approval in 2014 for an investigational device exemption trial in the treatment of thoracic aortic aneurysms that require coverage of the left subclavian artery. Gore also recently gained approval to begin another early feasibility study for the GORE TAG Thoracic Branch Endoprosthesis to assess the treatment of Zone 0/1 aortic arch aneurysms. In November 2014, Gore enrolled the first two patients in an initial feasibility study of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis for the treatment of abdominal aortic aneurysms encroaching on or involving visceral branch vessels.

ABOUT W. L. GORE & ASSOCIATES

At Gore, we have provided creative therapeutic solutions to complex medical problems for more than 35 years. During that time, more than 35 million innovative Gore Medical Devices have been implanted, saving and improving the quality of lives worldwide. Our extensive family of products includes vascular grafts, endovascular and interventional devices, surgical meshes for hernia and soft tissue reconstruction, staple line reinforcement materials, and sutures for use in vascular, cardiac, and general surgery. We are one of a select few companies to appear on all of the US “100 Best Companies to Work For” lists since the rankings debuted in 1984.

 

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