Specializing in products for minimally invasive treatments for aortic disorders, Endologix, Inc. (Irvine, CA) has received Investigational Device Exemption (IDE) conditional approval from the FDA for its Ventana fenestrated stent graft system. The approval enables the company to begin clinical trials of the device to treat juxtarenal and pararenal aortic aneurysms. The company expects to start enrolling patients at a few centers in the U.S. before the end of this year.
The Ventana device is a new aortic extension designed to be used in conjunction with the company’s AFX Endovascular AAA system and Xpand renal stent grafts. The AFX system is commercially available in the United States and expected to be available in other 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.
John McDermott, the company’s president and CEO explained that he is “encouraged by the initial positive outcomes with Ventana in clinical studies outside the U.S.” He adds that “[i]t is estimated that 20% of diagnosed abdominal aortic aneurysms are not treatable with currently approved endovascular devices” and that the “Ventana potentially provides these patients with an innovative and less-invasive alternative to open repair.”