Terumo Aortic has announced that the US Food and Drug Administration (FDA) has granted approval of the Thoraflex Hybrid frozen elephant trunk (FET) device for commercial sale in the USA for the treatment of patients with complex aortic arch disease.
Thoraflex Hybrid is the first-of-its-kind device used in FET repair in the USA 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 and 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.
Principal investigator Joseph Coselli (Baylor College of Medicine, Houston, USA) commented: “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. They can now be treated any time in a single-stage procedure with this hybrid device, rather than in two procedures, which has been the conventional pathway in the [USA] 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.”
Coselli continued: “Thoraflex Hybrid facilitates secondary interventions for distal extension and, in the USA, is designated for usage with Terumo Aortic’s RelayPro NBS device. This unique labelling aspect provides surgeons with additional confidence should patients have continued aortic disease progression.”
Paul Kuznik, president of Terumo Aortic North America, added: “The FDA approval of Thoraflex Hybrid is a tremendous opportunity for Terumo Aortic in the [USA]. This innovative hybrid device complements our open surgical graft and endovascular portfolio making us one of the strongest medical device companies within the aortic space, helping to deliver our commitment to provide solutions for every aorta.”