FDA approves Thoraflex Hybrid device for complex aortic arch disease
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The FDA approved the Thoraflex Hybrid Frozen Elephant Trunk device for commercial sale in the U.S. for treatment of adults with complex aortic arch disease, according to an industry press release.
The Thoraflex Hybrid (Terumo Aortic) is the first of its kind device used in frozen elephant trunk repair in the U.S.; the device received breakthrough device designation in 2021 by the FDA.
According to the release, 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.
“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,” Joseph Coselli, MD, professor and executive vice chair of the division of cardiothoracic surgery at Baylor College of Medicine in Houston, said in the release. “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.”
In the release, Coselli also said the device facilitates secondary interventions for distal extension and, in the U.S., is designated for use with Terumo Aortic’s RelayPro NBS device. “This unique labelling aspect provides surgeons with additional confidence should patients have continued aortic disease progression,” Coselli said.
Thoraflex Hybrid received CE Mark approval in 2012.
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