Terumo Aortic’s Thoraflex Hybrid Frozen Elephant Trunk Device Launched in the United States

July 4, 2022—Terumo Aortic annnounced that the first commercial implantation of the company’s Thoraflex Hybrid frozen elephant trunk (FET) device in the United States was performed by Joseph Coselli, MD. Dr. Coselli is Professor, Executive Vice Chair, Division of Cardiothoracic Surgery, Baylor College of Medicine in Houston, Texas, and serves as Principal Investigator of the Thoraflex Hybrid study.

“The procedure was very successful, the device performed well, and the patient is making a good recovery,” commented Dr. Coselli in the company’s press release. He continued, “Thoraflex Hybrid is the first-of-its-kind device used in FET repair in the United States, and it will allow United States 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 for those with suitably limited disease instead of two procedures, which has been the conventional pathway in the United States for this group of patients.”

On April 20, the company announced FDA approval of the Thoraflex Hybrid FET device for the treatment of patients with complex aortic arch disease. In Europe, Thoraflex Hybrid received CE Mark approval in 2012.

According to Terumo Aortic, Thoraflex Hybrid is a single-use medical device combining the company’s Gelweave polyester graft with a nitinol self-expanding stent graft. It is indicated for the open surgical repair or replacement of damaged or diseased vessels of the aortic arch and repair of the descending thoracic aorta with or without involvement of the ascending aorta, in cases of aneurysm and/or dissection.