GORE EXCLUDER Iliac Branch Endoprosthesis Approved in Japan

W. L. Gore & Associates Inc. announced the first implants in Japan of the GORE EXCLUDER Iliac Branch Endoprosthesis (IBE). Gore has received Shonin approval from the Japanese Ministry of Health, Labour and Welfare to market the 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.
 
With more than 2,500 commercial implants worldwide, the device is a complete, fully engineered system (Gore designed iliac branch and internal iliac components), which received CE Mark in 2013, registration in Australia and New Zealand in 2015, and U.S. Food and Drug Administration and Health Canada approval in 2016.
 
Used in conjunction with the GORE EXCLUDER AAA Endoprosthesis, the IBE preserves blood flow in the external and internal iliac arteries. The IBE leverages the design and experience acquired from more than 20 years and 285,000 patients treated* with the GORE EXCLUDER AAA Endoprosthesis and utilizes the same durable, expanded polytetrafluoroethylene (ePTFE) graft and nitinol stent material. The IBE offers an all-in-one System with improved outcomes for the treatment of iliac artery aneurysms while preserving flow to the iliac arteries. Preservation of blood flow in the internal iliac arteries is found to avoid pelvic flow disruption and reduce the rate of complications that can include buttock claudication, sexual dysfunction, and colonic ischemia.
 
“Providing a simple and straightforward procedure, the IBE preserves flow to the internal iliac arteries during EVAR,” said Takao Ohki, M.D., Ph.D., chairman and professor of the Department of Surgery at Jikei University School of Medicine in Tokyo, who successfully performed the first two implants in Japan. “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 6.5-13.5 mm for the internal iliac arteries, and a treatment range of 6.5-25 mm for the external iliac arteries. The delivery profile of the loaded catheter allows the use of a 16 Fr introducer sheath for the iliac branch component, and a flexible 12 Fr, reinforced introducer sheath for the internal iliac component.
 
“We are pleased to receive approval of this device in regions worldwide as it continues to provide an iliac branch solution for a patient group with a previously unmet treatment need,” said Eric Zacharias, Vascular Business leader. “Together with physicians, we have spent the past 20 years determining patient needs and continually working to improve our aortic family of devices to provide solutions physicians trust and patients count on. The IBE is an exciting innovation that stems from our mission to effectively treat aortic aneurysms through minimally invasive means.”

* Based on the number of Trunk-Ipsilateral Leg components distributed.
     
Gore Medical Products Division engineers devices that treat a range of cardiovascular and other health conditions. With more than 40 million medical devices implanted over the course of more than 40 years, Gore builds on its legacy of improving patient outcomes through research, education and quality initiatives.
 
W. L. Gore & Associates is a global materials science company dedicated to transforming industries and improving lives. Founded in 1958, Gore has built a reputation for solving complex technical challenges in the most demanding environments—from revolutionizing the outerwear industry with GORE-TEX fabric to creating medical devices that improve and save lives to enabling new levels of performance in the aerospace, pharmaceutical and mobile electronics markets, among other industries. Headquartered in Newark, Del., Gore employs approximately 10,000 Associates and generates annual revenues that exceed $3 billion.