Anteris Technologies receives FDA approval to initiate PARADIGM trial

Anteris announced it has received U.S. Food and Drug Administration, FDA, approval to initiate PARADIGM, its global Investigational Device Exemption, IDE, clinical trial which is designed to evaluate the DurAVR Transcatheter Heart Valve, THV, in patients with severe calcific aortic stenosis and to support a future PMA submission. “We are extremely pleased to receive FDA approval for the PARADIGM Trial, which allows us to commence patient recruitment in the United States**. 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,” commented Vice Chairman and CEO, Wayne Paterson.