US Pivotal Study Begins for TriVascular's Ovation EVAR System

May 7, 2010—TriVascular, Inc. (Santa Rosa, CA) announced the commencement of a clinical study of its Ovation abdominal stent graft. The study will evaluate the safety and effectiveness of the Ovation system in support of TriVascular's application for market approval in the United States. Manish Mehta, MD, is the study's national principal investigator. Gregory Mishkel, MD, implanted the Ovation in the study's first EVAR procedure.

According to the company, the Ovation is a low-profile system designed to expand the patient population suitable for endovascular aortic repair (EVAR) by addressing a wider range of diseased anatomy. TriVascular advised that the Ovation is an investigational device and currently not approved for sale. The study is being conducted in the United States under an investigational device exemption from the Food and Drug Administration.

“I am pleased to be partnering with TriVascular on this important clinical effort,” commented Dr. Mehta. “I believe the Ovation abdominal stent graft has the potential to considerably improve upon currently available stent grafts, particularly in its ability to accommodate complex aortic necks and difficult iliac access.”

Dr. Mishkel reported, “The Ovation abdominal stent graft performed very well and was easy to use. We are excited to participate in the clinical study of this novel, next-generation device. The significantly reduced profile of the delivery catheter will increase the pool of patients to whom I can offer EVAR.”