FDA Approves TriVascular's Ovation Abdominal Stent Graft System

October 5, 2012—TriVascular, Inc. (Santa Rosa, CA) announced that the company's Ovation abdominal stent graft system has received US Food and Drug Administration (FDA) premarket approval for the treatment of abdominal aortic aneurysms via endovascular aneurysm repair (EVAR).

The Ovation features a low profile for delivery through a 14-F (4.7 mm, outer diameter) catheter, and with a broader set of indications for use, the device expands the pool of patients eligible for EVAR, stated the company.

TriVascular noted in its announcement that the Ovation abdominal stent graft system received CE Mark approval in August 2010. In the United States, Ovation received humanitarian device exemption approval for EVAR in November 2011.

According to the company, the Ovation pivotal study, which was conducted under an FDA investigational device exemption, treated 161 patients at 36 sites from the United States, Germany, and Chile. Approximately 40% of patients treated had complex anatomies, with proximal neck lengths shorter than 10 mm, distal access vessels smaller than 6 mm, or both. The method of vessel access was left to the discretion of the physician, with 43% of patients treated percutaneously.

In the study, there were no reported device-related major adverse events, no aneurysm ruptures, and no conversions from EVAR to open surgical repair. An independent imaging core laboratory reported 0% type I and type III endoleaks and 0% migration.

Manish Mehta, MD, of The Vascular Institute for Health & Disease in Albany, New York, served as the Principal Investigator for the study.

“I am proud to have the opportunity to work with the internationally recognized vascular experts that participated in this trial and treated a global cohort of patients with abdominal aortic aneurysms,” commented Dr. Mehta in TriVascular's press release. “The 1-year clinical trial outcomes, particularly in patients with complex anatomies, demonstrate the excellent safety and effectiveness of the Ovation stent graft system. With Ovation's FDA approval, we can confidently offer EVAR to more patients since we now have access to a very safe and effective low-profile system.”