Terumo Aortic today announced that the Food and Drug Administration (FDA) has granted approval of the Thoraflex Hybrid frozen elephant trunk device for commercial sale in the U.S. for the treatment of patients with complex aortic arch disease.
Thoraflex Hybrid is the first-of-its-kind device used in frozen elephant trunk repair in the U.S. and was granted Breakthrough Device designation by the FDA in 2021.
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 descending aorta, with or without involvement of the ascending aorta in cases of aneurysm and/or dissection.
“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,” said Joseph Coselli, MD, professor and executive vice chair in the division of cardiothoracic surgery at Baylor College of Medicine in Houston, who was the principal investigator of the Thoraflex Hybrid investigational device exemption (IDE) study.
“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.
“Thoraflex Hybrid facilitates secondary interventions for distal extension and, in the United States, is designated for usage with Terumo Aortic’s RelayPro NBS device. This unique labeling aspect provides surgeons with additional confidence should patients have continued aortic disease progression.”
Thoraflex Hybrid received CE mark approval in 2012.