TriVascular Initiates OVATION Postmarket Registry in Europe

April 9, 2011—TriVascular, Inc. (Santa Rosa, CA) announced the start of the OVATION study at the 33rd annual Charing Cross International Symposium in London. Matt Thompson, MD, is serving as the coordinating investigator for OVATION and leads the study's steering committee.

According to the company, OVATION is a multicenter, prospective, postmarket study that will evaluate the safety and performance of the company's Ovation abdominal stent graft system. The study will evaluate endovascular repair of abdominal aortic aneurysms with the device in the real-world setting of routine clinical practice. The company expects that the study will enroll 500 patients at 30 sites in Europe.

Patients who meet the study's single-arm inclusion criteria will be treated with the Ovation abdominal stent graft and followed for 5 years. The study's primary endpoint is treatment success, 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 III endoleak, conversion to open surgical repair, stent graft migration, and stent graft occlusion.

The company stated that the low-profile device features a 14-F outer diameter. TriVascular launched the Ovation abdominal stent graft system in Europe in January 2011. In the United States, Ovation is an investigational device and is not currently available for sale. The United States study, which was conducted under an investigation device exemption, completed enrollment in March 2011.