Terumo Aortic this week said it received FDA breakthrough device designation for its Thoraflex Hybrid stented device for complex aortic arch repair.
Thoraflex Hybrid is a single-use device that combines a gelatin-sealed woven polyester graft with a Nitinol self-expanding stent graft. It is designed for the surgical repair or replacement of damaged or diseased aortic arch and descending aorta vessels.
“This breakthrough designation from the FDA will allow U.S. physicians to treat patients who may be at great risk of rupture with a device that brings the primary benefit of requiring a single-stage procedure instead of the conventional treatment involving two procedures thus lowering the risk of patient mortality and potentially reducing overall operating time and hospital costs,” Joseph Coselli, vice chair and chief of the division of cardiothoracic surgery at Baylor College of Medicine, said in a news release.
Terumo’s Thoraflex Hybrid received CE Mark approval in 2012.