Following the recent approval by the Food and Drug Administration (FDA) of the Thoraflex Hybrid frozen elephant trunk (FET) device for the treatment of patients with complex aortic arch disease, Terumo Aortic has now announced the first commercial implant of the device in the United States.
Thoraflex Hybrid is a single use medical device combining a 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.
The implant was performed by the principal investigator of the Thoraflex Hybrid study, Joseph Coselli, MD, professor and executive vice chair in the division of cardiothoracic surgery at Baylor College of Medicine in Houston, Texas.
“The procedure was very successful, the device performed well, and the patient is making a good recovery”, said Coselli. “Thoraflex Hybrid is the first of its kind device used in FET repair in the United States and it 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 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.”
Thoraflex Hybrid received CE mark approval in 2012 and FDA approval in 2022.