Trivascular, a medical device manufacturer based in California, recently received premarket approval from the United States Food and Drug Administration for its Ovation-brand abdominal stent graft system.
One year ago, Trivascular received FDA approval for the Ovation product line through the humanitarian use approval pathway. The Ovation stent graft system is designed to treat weak, diseased or bulging sections of an artery wall during vascular surgeries. The device is made of a specialized plastic tube that is supported with polymer-filled rings. These rings surround a metallic stent which is delivered to an affected artery in the body with a specialized catheter.
During the same time last year, the company also received HDE approval for another use of its Ovation system. The device received approval for use in patients with femoral artery or small iliac access of seven millimeters or less. According to the FDA similar delivery systems on the market have a diameter of seven millimeters. Since the Ovation endograft is 4.7 millimeters in diameter, it can be used in a variety of different applications.
According to Christy Foreman, a mid-level director at the FDA, "The unique construction of the 20-mm Ovation system allows it to fit into a narrower delivery catheter than other endografts currently on the market. FDA's approval of this product will enable some patients with small blood vessels to be treated via minimally-invasive surgery who did not previously have this option.”