In a major milestone for the Santa Rosa med-tech developer, TriVascular Inc. announced Friday that it has won federal approval to sell its first U.S. product, a stent graft system for repairing weakened aortas.
The U.S. Food and Drug Administration has approved the company's Ovation Abdominal Stent Graft System.
The system can repair abdominal aortic aneurysms, bulges in the aorta that can rupture, causing internal bleeding and death. The condition affects about 2 million Americans, but only about 200,000 cases are diagnosed across the country each year, the company said.
"I am very proud of our entire team for achieving this impressive milestone," TriVascular CEO and Chairman Christopher G. Chavez said in a statement.
The company, with more than 200 employees in Santa Rosa, won approval in 2010 to sell the Ovation system in Europe. To date it has been used to successfully treat more than 1,000 patients worldwide.
That includes 161 patients treated in the year-long clinical trials needed to gain FDA approval. None of the patients treated at 36 trial sites in the U.S., Germany and Chile suffered any "major adverse events" related to the device, the company said. No patients suffered ruptures of the aorta or needed conventional surgery as a follow-up to repair any damage, it said.
Manish Mehta, director of endovascular services at the Vascular Institute for Health & Disease in Albany, N.Y., said the results demonstrate "the excellent safety and effectiveness of the Ovation stent graft system."
TriVascular was founded in 1998, acquired in 2005 by technology giant Boston Scientific and shut down a year later in a cost-cutting move. It reopened in 2008 after venture funds paid $65 million to acquire the technology and re-start the dormant business.
In June the company announced it had raised $60 million in new venture capital and would use the funds to help launch Ovation in the U.S. market.
TriVascular spokeswoman Meredith Huetter said the company has begun hiring workers for its U.S. sales force. It has not released how many workers it plans to employ, but will increase the number with the growth of business here, she said.