On 6 September 2011, Endologix announced that it has received Investigational Device Exemption (IDE) conditional approval from the FDA to begin US clinical trials to evaluate the Ventana Fenestrated Stent Graft System for the endovascular repair of juxtarenal and pararenal aortic aneurysms. Endologix expects to begin enrolling patients at a few centres in the USA before the end of this year.
The Ventana device is a new aortic extension designed to be used with the AFX Endovascular Abdominal Aortic Aneurysm System and Xpand renal stent grafts. The AFX system is commercially available in the USA and expected to be available in other international markets in 2012. The Ventana and Xpand stent grafts are not approved for marketing in the USA or abroad and are restricted to investigational use only.
US national principal investigator Daniel G Clair, chairman, Department of Vascular Surgery, Cleveland Clinic Foundation, Cleveland, commented, “The initial clinical experience with Ventana outside of the USA has been very positive. 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 USA and furthering the research efforts on this promising technology.”
John McDermott, president and chief executive officer said, “We are delighted to receive the US FDA conditional IDE approval, and are encouraged by the initial positive outcomes with Ventana in clinical studies outside the USA. It is estimated that 20% of diagnosed abdominal aortic aneurysms are not treatable with currently approved endovascular devices. Ventana potentially provides these patients with an innovative and less-invasive alternative to open repair. We look forward to collaborating with the Ventana clinical investigators on the IDE trial and are hopeful to provide a new endovascular therapy for patients with complex aortic aneurysms in the years ahead.”