FDA approves Thoraflex Hybrid device for complex aortic arch disease

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

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