The U.S. Food and Drug Administration (FDA) approved initiation of the PARADIGM trial this week, which is evaluating the Anteris DurAVR® transcatheter heart valve (THV) for patients with severe calcific aortic stenosis (AS). PARADIGM (A Prospective rAndomized tRial Assessing the safety and effectiveness of the DurAVR® bIomimetic valve designed for physioloGic flow compared to CoMmercial TAVR devices) is the first randomized controlled trial to evaluate the device compared with commercially available transcatheter aortic valve replacement (TAVR) devices. The study enrollment goal is 1,000 patients across the U.S., Europe and Canada. Patients will be randomized 1:1 to receive the DurAVR® THV or TAVR with a commercially available THV. Anteris Technologies Global Corp designed the balloon-expandable DurAVR® device with interventional cardiologists from around the world. "We are extremely pleased to receive FDA approval for the PARADIGM Trial, which allows us to commence patient recruitment in the United States**," said Wayne Paterson, MBA, Vice Chairman and CEO of Anteris, in an Anteris press release on Monday. “This milestone, together with the recent launch of the trial and first patients treated in Denmark, represents a significant achievement and a key step forward in advancing this life-saving technology worldwide for patients living with aortic stenosis, a debilitating and progressive condition.” The trial is co-chaired by Michael J. Reardon, MD, from the Houston Methodist Hospital, Texas, and Stephan Windecker, MD, from Bern University Hospital, Switzerland. **With Approval From the Institution Review Board (IRB) Image Credit: https://anteristech.com/technology.html