W.L. Gore & Associates said today it won Japanese regulatory approval for its Gore Excluder iliac branch endoprosthesis and that the 1st implants of the device had been performed in the region.
The Newark, Del.-based company said that the Excluder IBE was the 1st off-the-shelf iliac branch solution approved in the country, and the only device indicated for the endovascular treatment of common iliac artery aneurysms or aortoiliac aneurysms.
“Providing a simple and straightforward procedure, the IBE preserves flow to the internal iliac arteries during EVAR. 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,” Dr. Takao Ohki of Tokyo’s Jikei University School of Medicine said in a prepared statement. Dr. Ohki was the operating physician who successfully performed the 1st two implants with the IBE in Japan.
The IBE device is designed to be used in conjunction with Gore’s Excluder AAA endoprosthesis for treating abdominal aortic aneurisms. The Excluder device is designed to treat aneurysms in the iliac arteries as they branch off from the aorta, the company said.
“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. 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,” vascular business lead Eric Zacharias said in a press release.
In March, Gore said it won FDA premarket approval for and launched its Viatorr Tips endoprosthesis with controlled expansion designed for transjugular intrahepatic portosystemic shunt procedures.