Terumo Aortic has announced the first commercial implant of the Thoraflex Hybrid frozen elephant trunk (FET) device in the US.
Thoraflex Hybrid FET combines a Gelweave polyester graft and Nitinol self-expanding stent graft.
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The single-use medical device is designed for the open surgical repair or replacement of aortic arch artery vessels that are damaged or diseased as well as for repair of the descending thoracic aorta with or without involving the ascending aorta.
In 2012, the device received CE Mark approval, followed by FDA clearance in April.
Terumo Aortic had sold more than 13,000 Thoraflex Hybrid FET devices worldwide over the last ten years.
Terumo Aortic North America president Paul Kuznik said: “This commercial implant represents a significant milestone for the company and a tremendous opportunity for Terumo Aortic in the United States.
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By GlobalData“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.”
The Thoraflex Hybrid study principal investigator professor Joseph Coselli, executive vice-chair of the Cardiothoracic Surgery Division at Baylor College of Medicine US, implanted the device.
Coselli said: “The procedure was very successful, the device performed well, and the patient is making a good recovery.
“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.”
