FDA Approval for Ovation Prime Abdominal Stent Graft System

The U.S. Food & Drug Administration (FDA) gave approval of the TriVascular Inc. Ovation Prime Abdominal Stent Graft System for the treatment of abdominal aortic aneurysms (AAA). Ovation Prime builds upon the strong clinical experience of TriVascular’s Ovation stent graft by improving delivery system attributes while further enhancing ease of use. Delivered through a 14 French (4.7mm) outer diameter catheter, Ovation Prime is the lowest profile commercially available system for endovascular aortic repair (EVAR). Ovation Prime utilizes innovative polymer-filled sealing ring technology and has the broadest indications for use (IFU) of any endovascular graft, thereby expanding the pool of patients eligible for EVAR.

“I was impressed by the Ovation Prime system,” comments Manish Mehta, MD, MPH, director of endovascular services, Vascular Institute for Health & Disease, Albany, NY, who performed the first U.S. implant of Ovation Prime. “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.”

Development of Ovation Prime was in close collaboration with a global network of endovascular specialists. The new delivery system is designed to simplify device preparation, enhance deliverability, increase visualization, and facilitate optimized orientation and cannulation, all while maintaining the excellent implant performance of Ovation.

The Ovation IDE pivotal study included 36 sites from the United States, Germany, and Chile, with a total of 161 patients treated. There were no device related major adverse events, no aneurysm ruptures, and no conversions from EVAR to open surgical repair reported in the study. An independent imaging core laboratory reported 0% type I and type III endoleaks and 0% migration. Nearly 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. Worldwide, more than 1,300 patients have been treated with Ovation.

“Our central purpose is to help physicians improve the lives of patients suffering from aortic disease through excellence in research, manufacturing, and service,” states Christopher G. Chavez, chairman, CEO, and president, TriVascular, Inc. “We are pleased to have introduced Ovation Prime into Europe and now the United States. Ovation Prime is evidence of our commitment to listen to clinical feedback and provide innovative, timely, and relevant improvements that provide the best solution to physicians and their patients. We are very grateful to all of our clinical partners around the world whose commitment to patient care and innovation helped fuel this and other next generation products.”