FDA Approves TriVascular's Ovation Prime AAA Stent Graft System

January 21, 2013—TriVascular, Inc. (Santa Rosa, CA) announced US Food and Drug Administration approval of the Ovation Prime stent graft system for the treatment of abdominal aortic aneurysms. The low-profile Ovation Prime is delivered through a 14-F (4.7-mm) outer diameter catheter and features TriVascular's polymer-filled sealing ring technology to provide a broad indications-for-use spectrum for endovascular aneurysm repair.

Manish Mehta, MD, Director of Endovascular Services at the Vascular Institute for Health & Disease in Albany, New York, performed the first US implant of Ovation Prime. In TriVascular's press release, Dr. Mehta commented, “I was impressed by the Ovation Prime system. We had a very favorable experience with Ovation in the clinical study and were excited to use Ovation Prime. The delivery system enhancements make Ovation even easier to use, while building upon the confidence that comes from the strong clinical data.”

TriVascular stated that the Ovation Prime was developed in close collaboration with a global network of endovascular specialists. The device's new delivery system is designed to simplify device preparation, enhance deliverability, increase visualization, and facilitate optimized orientation and cannulation.

In its announcement, the company advised that the Ovation pivotal study included 36 sites in the United States, Germany, and Chile and was composed of 161 patients. 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.

The company reported that there were no device-related major adverse events, no aneurysm ruptures, and no conversions from endovascular aneurysm repair to open surgical repair reported in the study. Additionally, an independent imaging core laboratory reported 0% type I and type III endoleaks and 0% migration.