Anteris Technologies has received regulatory clearance from the French National Agency for Medicines and Health Products Safety (ANSM) for the DurAVR transcatheter heart valve (THV) global pivotal trial in patients with severe calcific aortic stenosis—the PARADIGM trial.
This authorisation marks a significant milestone in the company’s clinical and regulatory strategy and enables patient recruitment to commence at leading centres in France, Anteris said in a press release.
“Securing French regulatory clearance is an important step in the execution of the PARADIGM trial,” said Wayne Paterson, vice chairman and chief executive officer of Anteris. “France represents a strategically important market with highly experienced centres and investigators, reinforcing the quality and conduct of the study.”
The company continues to advance its global clinical strategy, with ongoing site activations and patient enrolment across the USA and Europe.
The PARADIGM trial is a prospective randomised controlled trial which will evaluate the safety and effectiveness of the DurAVR valve compared to commercially available transcatheter aortic valve implantation (TAVI) systems.
The head-to-head study will enrol approximately 1,000 patients in the ‘all comers randomised cohort’ with 1:1 randomisation of patients who will receive either the DurAVR THV or TAVI using commercially available and approved THVs. The trial will assess non-inferiority on a primary composite endpoint of all-cause mortality, all stroke and cardiovascular hospitalisation at one year post procedure.
