Terumo Thoraflex Hybrid
Terumo Aortic received FDA breakthrough device designation in April 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. It became the world’s first multi-branched “frozen elephant trunk” prosthesis when it received CE Mark approval in 2012.