Anteris Technologies Global (NASDAQ: AVR; ASX: AVR) has received full regulatory clearance from the French National Agency for Medicines and Health Products Safety (ANSM) enabling patient recruitment to begin in France for the DurAVR Transcatheter Heart Valve (THV) global PARADIGM pivotal trial in patients with severe calcific aortic stenosis.
According to Anteris, the PARADIGM trial is a prospective randomized controlled trial which will evaluate the safety and effectiveness of the DurAVR THV compared to commercially available THV replacements.
In a statement, Wayne Paterson, vice chairman and CEO of Anteris, commented, “Securing French regulatory clearance is an important step in the execution of the PARADIGM trial. France represents a strategically important market with highly experienced centers and investigators, reinforcing the quality and conduct of the study.”
