TriVascular Initiates Postapproval Study of the Ovation Prime Abdominal Stent Graft System

July 17, 2013—TriVascular, Inc. (Santa Rosa, CA) announced the initiation of a United States postapproval study of the Ovation Prime abdominal stent graft system for the treatment of abdominal aortic aneurysms (AAAs).

According to TriVascular, the Ovation system received premarket approval from the US Food and Drug Administration in October 2012 and the Ovation Prime system received premarket approval in December 2012. Both systems are also approved and marketed throughout Europe. The Ovation Prime abdominal stent graft system has a broad set of indications for use, noted the company.

TriVascular advised that nearly 40% of the patients treated in the OVATION investigational device exemption (IDE) pivotal study had complex anatomies, with proximal neck lengths shorter than 10 mm, distal access vessels smaller than 6 mm, or, in some patients, both. The Ovation and Ovation Prime devices are approved for placement during percutaneous endovascular aneurysm repair (EVAR); 43% of patients treated in the OVATION IDE pivotal study were treated percutaneously.

The results of the OVATION IDE pivotal study showed no device-related major adverse events, no aneurysm ruptures, and no type I or type III endoleaks. In addition, TriVascular has enrolled and successfully treated more than 400 patients in a 30-center, European postmarket registry to contribute to the body of clinical evidence in support of the Ovation system.

The prospective, multicenter postapproval study will further evaluate the safety and effectiveness of the Ovation Prime system in a routine clinical setting. As in the IDE trial and the postmarket registry study, the postapproval study will include patients with challenging anatomies given the Ovation device's expanded indications for use.

Syed Hussain, MD, serves as the study's National Principal Investigator. Dr. Hussain is Director of Vascular and Endovascular Surgery at OSF/HeartCare MidWest and Assistant Clinical Professor of Surgery at University of Illinois College of Medicine in Peoria, Illinois.

In the company's press release, Dr. Hussain commented, “The Ovation device allows us to treat AAA patients that otherwise would not have been candidates for EVAR therapy. In our clinical experience, we have found the Ovation stent graft's low profile and unique O-ring sealing technology to be highly effective in treating both straightforward and challenging anatomies. We are impressed with the Ovation system's capability to expand EVAR to a broader AAA patient population including patients with narrow access arteries, short aortic necks, and other challenging anatomies. We are very excited to partner with TriVascular on this study.”