Gore receives regulatory approval for Excluder iliac branch endoprosthesis in Japan

Gore has received Shonin approval from the Japanese Ministry of Health, Labour and Welfare to market the Excluder iliac branch endoprosthesis (IBE), and is currently in discussion regarding reimbursement for this region.

The IBE is the first off-the-shelf iliac branch solution approved in Japan and the only device indicated for the endovascular treatment of common iliac artery aneursyms or aortoiliac aneursyms. The first implantations in the country have taken place.

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

Used in conjunction with the Gore Excluder AAA endoprosthesis, the IBE is designed to preserve blood flow in the external and internal iliac arteries. The device uses the same expanded polytetrafluoroethylene (ePTFE) graft and nitinol stent material as the AAA endoprosthesis.

An “All-in-One” system, the device offers improved outcomes for the treatment of iliac artery aneurysms with preservation of flow to the iliac arteries, according to a press release.

“Providing a simple and straightforward procedure, the IBE preserves flow to the internal iliac arteries during EVAR,” says Takao Ohki, chairman and professor of the Department of Surgery at Jikei University School of Medicine in Tokyo, Japan, who successfully performed the first two implants in the country. “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 IBE system provides a treatment range of 6.5–13.5mm for the internal iliac arteries, and a treatment range of 6.5–25mm for the external iliac arteries. The delivery profile of the loaded catheter is intended to allow the use of a 16Fr introducer sheath for the iliac branch component, and a flexible 12Fr, reinforced introducer sheath for the internal iliac component.