Following the recent approval by the US 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 USA.
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, professor, executive vice chair, division of cardiothoracic surgery at Baylor College of Medicine (Houston, USA).
“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 US 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.”
Paul Kuznik, president of Terumo Aortic North America, added: “This commercial implant represents a significant milestone for the company and a tremendous opportunity for Terumo Aortic in the United States. 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.”
Thoraflex Hybrid received CE Mark approval in 2012 and FDA approval in 2022 with more than 13,000 devices sold commercially around the world over the past 10 years.