(Updates to add stock movement in the headline and last paragraph)
Anteris Technologies (ASX:AVR) received authorization from France's National Agency for Medicines and Health Products Safety to begin patient recruitment in its Paradigm pivotal trial of the DurAVR transcatheter heart valve for severe calcific aortic stenosis, according to a Monday statement by the company.
Calcific aortic stenosis is a condition where the aortic valve of the heart narrows or is blocked due to calcium buildup.
The Paradigm trial is a prospective randomized controlled study assessing the safety and efficacy of the DurAVR transcatheter heart valve versus commercially available transcatheter aortic valve replacement systems.
The clearance allows enrollment at leading French clinical centers, the company said.
The company's shares fell around 6% in recent Tuesday trade.