Endologix Receives IDE Approval to Study the Ventana Fenestrated Stent Graft System

September 6, 2011—Endologix, Inc. (Irvine, CA) announced that it has received investigational device exemption (IDE) conditional approval from the US Food and Drug Administration to begin clinical trials in the United States to evaluate the Ventana fenestrated stent graft system for the endovascular repair of juxtarenal and pararenal aortic aneurysms. The company expects to begin enrolling patients at a few centers in the United States before the end of this year.

According to Endologix, the Ventana device is a new aortic extension that is designed to be used with the company's AFX endovascular abdominal aortic aneurysm system and Xpand renal stent grafts. The AFX system is commercially available in the United States and is expected to be available in international markets in 2012. The Ventana and Xpand stent grafts are not approved for marketing in the United States or abroad and are restricted to investigational use only, the company advised.

“The initial clinical experience with Ventana outside of the United States has been very positive,” commented national Principal Investigator Daniel G. Clair, MD. “International results demonstrate proof of concept for this innovative system, which is the first off-the-shelf endovascular option for patients with juxtarenal and pararenal aortic aneurysms. On behalf of the Ventana IDE investigators, we look forward to initiating the clinical program in the United States and furthering the research efforts on this promising technology.”