April 29, 2020
Terumo Aortic’s Thoraflex Hybrid Device Granted FDA Breakthrough Device Designation
April 29, 2020—Terumo Aortic announced that the FDA has granted Breakthrough Device designation for the company’s Thoraflex Hybrid stented device for complex aortic arch repair.
Thoraflex Hybrid is indicated for the surgical repair or replacement of damaged or diseased vessels of the aortic arch and descending aorta in patients at risk for ruptured thoracic aortic aneurysm or aortic dissection. The device combines a gelatin-sealed woven polyester graft with a nitinol self-expanding stent graft. Thoraflex Hybrid received European CE Mark approval in 2012.
“This breakthrough designation from the FDA will allow United States 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 instead of the conventional treatment involving two procedures, thus lowering the risk of patient mortality and potentially reducing overall operating time and hospital costs,” commented Joseph Coselli, MD, in the company’s press release. Dr. Coselli serves as Principal Investigator for the Thoraflex Hybrid investigational device exemption study. He is Professor, Vice Chair and Chief, Division of Cardiothoracic Surgery at Baylor College of Medicine in Houston, Texas.
The purpose of the FDA’s Breakthrough Device designation program is to fast-track the regulatory review process for certain medical technologies and device-led combination products that satisfy certain criteria, including providing a more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The aim of the program is to provide patients and health care professionals with timely access to important breakthrough medical devices by accelerating their development, assessment, and review while preserving the statutory standards for premarket approval and 510(k) clearance.