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September 16, 2010
TriVascular's Ovation AAA System Receives CE Mark Approval
September 17, 2010—TriVascular, Inc. (Santa Rosa, CA), announced CE Mark approval for the Ovation abdominal stent graft at the European Society for Vascular Surgery annual meeting in Amsterdam, The Netherlands. The low-profile 14-F (outside diameter) system is designed to expand the patient population suitable for endovascular aortic repair (EVAR) by addressing a wide range of diseased anatomies.
The Ovation abdominal stent graft system has been implanted in approximately 50 patients in Chile, Germany, and the United States to evaluate the safety and performance of the device. Manish Mehta, MD, is the lead investigator for the pivotal study of the device in the United States, where the Ovation abdominal stent graft system is an investigational device and currently not approved for sale.
“The Ovation system is a novel technology that optimizes the two most important requirements for EVAR, fixation, and seal,” commented Michael Dake, MD. “Across a broad cohort of patients, the clinical results are very compelling.”
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