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March 21, 2010
TriVascular Begins European Study of the Ovation Abdominal Stent Graft
March 22, 2010—TriVascular, Inc. (Santa Rosa, CA) announced the commencement of the European clinical study to evaluate the safety and performance of its Ovation abdominal stent graft. The low-profile system is designed to expand the patient population suitable for endovascular aortic repair by addressing a wider range of diseased anatomy. The company intends that the study results will support an application for CE Mark approval in Europe. In the United States, the Ovation system is an investigational device and is not approved for sale, advised the company.
“The Ovation abdominal stent graft performed exceptionally well,” commented the study's principal investigator, Thomas Nolte, MD, who performed one of the first implants of the device. “The clinical benefits of the reduced profile and unique sealing technology were evident immediately. I believe this offering will expand the pool of patients to whom I can offer an endovascular solution.”
Horst Sievert, MD, who also performed initial cases, used a bilateral percutaneous approach to gain femoral access. Dr. Sievert noted, “The system was easy to use and addresses many of the limitations of current-generation devices, especially in cases of difficult anatomy and iliac access.”
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