TriVascular's OVATION Postmarket Registry Begins Enrollment

July 25, 2011—TriVascular, Inc. (Santa Rosa, CA) announced the commencement of enrollment in the OVATION study—a multicenter, prospective, European postmarket registry. The study will evaluate the company's Ovation abdominal stent graft for treatment of abdominal aortic aneurysms in the real-world setting of routine clinical practice. The study will enroll 500 patients at 30 sites in Europe. Matt Thompson, MD, is serving as the study's Coordinating Investigator.

According to the company, patients enrolled in the study will undergo treatment using TriVascular's Ovation abdominal stent graft and be followed for 5 years. The study's primary endpoint is treatment success, which is a composite of technical and clinical success at 12 months. Technical success includes successful delivery and deployment of the stent graft. Clinical success includes freedom from aneurysm expansion, aneurysm rupture, type I and type III endoleak, conversion to open surgical repair, stent graft migration, and stent graft occlusion.
 


“It is an honor to be the first site to enroll a patient in TriVascular's OVATION study,” commented Professor Martin Storck, MD, of Städtisches Klinikum Karlsruhe in Karlsruhe, Germany. “Ovation's low-profile, 14-F outer diameter design and sealing ring technology show great promise in the treatment of abdominal aortic aneurysms across a broad patient population.” 
 


TriVascular's Ovation abdominal stent graft system was launched commercially in Europe in January 2011. In the United States, Ovation is an investigational device that is not available for sale.