Terumo Aortic announces US FDA breakthrough device designation for Thoraflex Hybrid device

Thoraflex Hybrid stented device Terumo Aortic today announced that the US Food and Drug Administration (FDA) has granted breakthrough device designation for its Thoraflex Hybrid stented device for complex aortic arch repair. The purpose of the FDA’s breakthrough device designation programme is to fast-track the regulatory review process for certain medical technologies and device-led [...]