Terumo Aortic Gains FDA’s Premarket Approval for its Thoraflex Cardiac Device

UK-based Terumo Aortic has received the FDA’s premarket approval for its Thoraflex Hybrid device for the treatment of patients with complex aortic arch disease.

The single-use device is for so-called “Frozen Elephant Trunk” procedures as a hybrid stent-graft prosthesis to repair or replace damaged or diseased vessels of the aortic arch and descending aorta.

The device, which combines a polyester graft with a self-expanding stent, was designated a Breakthrough Device by the FDA last year.