Gore's Excluder Iliac Branch Endoprosthesis Approved in Japan

May 24, 2017—Gore & Associates announced the first implantation procedures in Japan of the company's Excluder iliac branch endoprosthesis (IBE), which received Shonin approval from the Japanese Ministry of Health, Labor, and Welfare. The Excluder IBE is indicated for the endovascular treatment of common iliac artery aneurysms or aortoiliac aneurysms. The company is seeking reimbursement for Japan.

The first two procedures were performed by Takao Ohki, MD, Chairman and Professor of the Department of Surgery at Jikei University School of Medicine in Tokyo, Japan.

In Gore's announcement, Dr. Ohki commented, “Providing a simple and straightforward procedure, the IBE preserves flow to the internal iliac arteries during endovascular aneurysm repair. In many patients, it is imperative that iliac artery blood flow be maintained when possible to avoid complications that can result when these arteries are sacrificed. The IBE will not only reduce complications but also expand the indication for less invasive endovascular treatment for patients that were rejected due to the inability to preserve internal iliac arteries. This is excellent news for Japanese patients.”

The device received European CE Mark approval in 2013, registration in Australia and New Zealand in 2015, and US Food and Drug Administration and Health Canada approval in 2016.

According to Gore, the IBE is used in conjunction with the company's Excluder abdominal aortic aneurysm (AAA) endoprosthesis to preserve blood flow in the external and internal iliac arteries. The IBE utilizes the same expanded polytetrafluoroethylene graft and nitinol stent material used in the Excluder AAA device.

The Excluder IBE provides a treatment range of 6.5 to 13.5 mm for the internal iliac arteries and a range of 6.5 to 25 mm for the external iliac arteries. The delivery profile of the loaded catheter allows the use of a 16-F introducer sheath for the iliac branch component and a 12-F, flexible, reinforced introducer sheath for the internal iliac component, stated the company.