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FDA approves new TriVascular device developed in Santa Rosa

Santa Rosa med-tech developer TriVascular Inc. announced Monday it has won federal approval to sell an updated version of its stent graft system for repairing weakened aortas.

The Ovation Prime system is a newer version of the stent graft system approved by the U.S. Food and Drug Administration last fall. That was the company's first product to win U.S. approval, though TriVascular won permission in 2010 to sell the device in Europe.

The stent graft system repairs abdominal aortic aneurysms, bulges in the aorta that can rupture, causing internal bleeding and death.

Ovation Prime has more flexibility to make its way through the femoral artery at the top of the leg, said TriVascular spokeswoman Meredith Huetter. The new device also has more "markers" that show up in X-ray-like imaging in order to better position the stent graft in the body.

TriVascular has more than 200 employees in Santa Rosa. Last June, the company announced it had raised $60 million to help launch its devices in the U.S. market.


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