FDA awards PMA to Trivascular for Ovation abdominal stent graft
California device maker Trivascular wins premarket approval for its Ovation abdominal stent graft system.
Medical device maker Trivascular won premarket approval for its Ovation stent graft system, almost precisely 1 year after the FDA granted the device approval under the humanitarian use device pathway.
The Ovation system is used to treat diseased, bulging or weak sections of the artery wall during endovascular repair procedures. The devices is comprised of a plastic tube supported by polymer-filled rings and a metallic stent, which is delivered to the affected area via a delivery catheter.