SANTA ROSA – TriVascular Inc. gained European approval for its Ovation Abdominal Stent Graft, the company announced today. It’s the first TriVascular product to be approved for the European market.
The company has been gearing up for overseas approval, opening an office in Switzerland and planning other European locations.
The stent represents a significant advance in abdominal stent graft technology, according to clinicians who participated in trials. Clinical testing took place in Chile and Germany. The Ovation is currently being tested in the U.S., where it has not yet received approval from the FDA.
“Commercial approval for Ovation is a huge milestone for our organization,” said Michael Chobotov, Ph.D., president and CEO of TriVascular, Inc. “As we invest in our international team, what excites me most is the prospect of bringing advanced technology to physicians and patients.”
The company employs 250 full time workers, mostly in its Santa Rosa headquarters, and another 100 part time.