Primary Enrollment Complete in Gore Excluder Iliac Branch Clinical Study

February 17, 2015—W. L. Gore & Associates announced it has completed primary enrollment in the Gore Excluder Iliac Branch clinical study. 

The study is a prospective, multicenter, nonrandomized, single-arm evaluation of the safety and effectiveness of the Gore Excluder Iliac Branch Endoprosthesis in treating common iliac artery aneurysms or aortoiliac aneurysms. Sixty-two patients were treated with the device, successfully meeting the US Food and Drug Administration (FDA) requirement of 60 enrollees. Gore states that the FDA has also approved a Continued Access Protocol (CAP) allowing 140 more patients to be treated with the device, with the CAP also including bilateral placement. 

In the company’s announcement, Darren Schneider, MD, provided context for the study and the clinical need it aims to address. “An estimated 20% to 40% 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 Dr. Schneider, who is 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.”