Evidence-based medicine

United States. Food and Drug Administration

Anteris Receives FDA Approval for PARADIGM Trial to Evaluate DurAVR(R) THV Compared to Commercial TAVR Devices

Anteris, a global structural heart company, has received approval from the U.S. Food and Drug Administration (FDA) to initiate a global Investigational Device Exemption (IDE) clinical trial, known as the PARADIGM Trial. This prospective randomized controlled trial will evaluate the safety and effectiveness of the DurAVR(R) Transcatheter Heart