International Trial Begins for the Endologix Ventana Stent Graft

November 2, 2010—Endologix, Inc. (Irvine, CA) announced the first clinical implant of the company's Ventana fenestrated stent graft, which was the first case in the pilot study of this endovascular platform. The patient's juxtarenal aneurysm was successfully excluded while maintaining full perfusion of the renal arteries and visceral vessels. Andrew Holden, MD, and Andrew Hill, MD, performed the procedure at Auckland City Hospital in New Zealand. Endologix will continue enrolling patients in international clinical studies in 2011. The results will be used to support international regulatory approvals to market the device, with international commercialization expected to commence in 2012.

According to Endologix, the Ventana fenestrated stent graft is an aortic extension designed to be used with the company's anatomically fixed Powerlink bifurcated stent graft. It was developed to provide an off-the-shelf treatment option for the endovascular repair of juxtarenal and certain pararenal aortic aneurysms (JAA/PAA).

“Given our extensive experience with aortic aneurysmal disease and understanding the limitations of all commercially available endovascular devices, we believe that Ventana has the potential to address a significant unmet clinical need—a minimally invasive alternative for patients presenting with JAA or PAA,” commented Dr. Holden.

Endologix also expects to submit an investigational device exemption (IDE) from the US Food and Drug Administration (FDA) to support initiation of a prospective, multicenter, clinical trial for the treatment of JAA/PAA utilizing the Ventana fenestrated stent graft in 2011. 

Daniel G. Clair, MD, of the Cleveland Clinic, who attended the procedure as a medical advisor, stated, "Unfortunately, many patients with JAA and PAA do not have much time to wait and need to be treated immediately to avoid aneurysm rupture. The Ventana off-the-shelf design is unique in that it represents a potential minimally invasive solution for these difficult-to-treat aneurysms. The device also leverages the good clinical results of the Powerlink design and anatomical fixation. I am pleased with the progress that Endologix has made developing this device and look forward to initiating a US multicenter clinical trial in 2011."