Gore won FDA approval for its GORE EXCLUDER Iliac Branch Endoprosthesis (IBE), what the company says is “the first off-the-shelf aortic branch device approved in the United States and the only device indicated for the endovascular treatment of common iliac artery aneurysms or aortoiliac aneurysms.” It’s made of the same ePTFE and nitinol materials as and is used along with the GORE EXCLUDER AAA Endoprosthesis to isolate the common iliac and motivate the flow through the external iliac and internal iliac arteries.
The devices comes in a range of sizes from 6.5 to 13.5 mm for interla iliac arteries and from 6.5 to 25 mm for the external iliacs. It’s introduced via the 16 Fr sized sheath for the iliac and 12 Fr for the internal iliac part.
The GORE EXCLUDER Iliac Branch Endoprosthesis has already been approved for implantation in Europe since 2013.
From the announcement:
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.
Product page: GORE EXCLUDER Iliac Branch Endoprosthesis…