SANTA ROSA -- TriVascular, Inc. has received premarket approval from the U.S. Food and Drug Administration for a stent system that treats abdominal aortic dissections, the first step in offering the product in the U.S.
With the premarket approval, the Santa Rosa-based medical device maker said it plans to create an organization that would build patient access in the U.S. TriVascular is directly marketing the Ovation system in select European countries while appointing independent distributors in other international markets.
The Ovation Abdominal Stent Graft System received initial approval in August 2010, which allowed patients to be studied in the U.S., Europe and Chile. To date, more than 1,000 patients worldwide have been successfully treated with the system, according to TriVascular.
Patients who were studied had no device-related "major adverse" health events, no aneurysm ruptures, and no conversions related to endovascular aneurysm repair, according to TriVascular.
“The one-year clinical trial outcomes, particularly in patients with complex anatomies, demonstrate the excellent safety and effectiveness of the Ovation stent graft system," said Manish Mehta, M.D., M.P.H., principal investigator of the study and director of endovascular services at The Vascular Institute for Health & Disease in Albany, New York.