The US Food and Drug Administration (FDA) has given TriVascular premarket approval (PMA) for its Ovation Abdominal Stent Graft System for the treatment of abdominal aortic aneurysms (AAA).
The FDA premarket approval was supported with an investigational device exemption (IDE) pivotal study of the Ovation system which included 161 patients from 36 sites in USA, Germany and Chile. There were no device related major adverse events, no aneurysm ruptures, and no conversions from EVAR to open surgical repair reported in the study. An independent imaging core laboratory reported 0% type I and type III endoleaks and 0% migration. Nearly 40% of patients treated had complex anatomies, with proximal neck lengths shorter than 10mm, distal access vessels smaller than 6mm, or both. The method of vessel access was left to the discretion of the physician, with 43% of patients treated percutaneously.
“I am proud to have the opportunity to work with the internationally recognised vascular experts that participated in this trial and treated a global cohort of patients with abdominal aortic aneurysms,” said Manish Mehta, director of Endovascular Services at The Vascular Institute for Health & Disease in Albany, New York, USA, who served as the principal investigator for the study. “The one-year clinical trial outcomes, particularly in patients with complex anatomies, demonstrate the excellent safety and effectiveness of the Ovation stent graft system. With Ovation’s FDA approval, we can confidently offer EVAR to more patients since we now have access to a very safe and effective low profile system.”
The Ovation Abdominal Stent Graft System received the CE mark in August 2010. In the United States, Ovation received the first ever humanitarian device exemption (HDE) approval for EVAR in November 2011.
TriVascular states that over 1,000 patients worldwide have been successfully treated with the Ovation Abdominal Stent Graft System.
TriVascular is directly marketing Ovation in select European countries while actively appointing independent distributors in other international markets. With PMA approval in hand, TriVascular plans to build a direct field service organisation domestically to drive patient access to Ovation in the United States.