Terumo Aortic’s Thoraflex Hybrid Device Approved by FDA for Complex Aortic Arch Disease Repair

April 20, 2022—Terumo Aortic announced that its Thoraflex Hybrid frozen elephant trunk (FET) device for the treatment of patients with complex aortic arch disease has been approved by the FDA for commercial sale in the United States.

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

Previously, Thoraflex Hybrid was granted Breakthrough Device designation by the FDA. In Europe, Thoraflex Hybrid received CE Mark approval in 2012.

Joseph Coselli, MD, serves as Principal Investigator for the Thoraflex Hybrid investigational device exemption study. Dr. Coselli is Professor, Executive Vice Chair, Division of Cardiothoracic Surgery, at Baylor College of Medicine in Houston, Texas.

“This approval represents a significant milestone in the treatment of patients who need total aortic arch replacement and have significant disease of the descending thoracic aorta,” commented Dr. Coselli in the company’s press release, “They can now be treated anytime in a single-stage procedure with this hybrid device rather than two procedures which has been the conventional pathway in the United States for this group of patients. This, in turn, has led to lowering the risk of major adverse events by 22.6%, in the first year, over traditional treatments.”

Dr. Coselli continued, “Thoraflex Hybrid facilitates secondary interventions for distal extension and, in the United States, is designated for usage with Terumo Aortic’s RelayPro NBS [nonbare stent] device. This unique labelling aspect provides surgeons with additional confidence should patients have continued aortic disease progression.”