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July 4, 2023
Terumo Aortic’s Thoraflex Hybrid Frozen Elephant Trunk Device Approved in Japan
July 4, 2023—Terumo Aortic announced that the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has granted approval of the Thoraflex Hybrid frozen elephant trunk (FET) device for commercial sale in Japan for the treatment of patients with complex aortic arch disease.
According to Terumo Aortic, Thoraflex Hybrid 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. The device combines the company’s Gelweave polyester graft with a nitinol self-expanding stent graft.
In the United States, FDA approval of the Thoraflex Hybrid FET device was announced in April 2022. The device was approved in Europe in 2012.
On June 13, 2023, Terumo Aortic announced the launch of the EXTEND global postapproval study for the Thoraflex Hybrid device that will be conducted in the United States and Europe.
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