Anteris Secures French Approval for 1,000-Patient DurAVR PARADIGM Trial
AVR•Anteris secured French ANSM clearance for its global PARADIGM Trial of the DurAVR Valve, enabling recruitment at leading French cardiac centers for severe calcific aortic stenosis patients. The 1,000-patient randomized study will compare DurAVR against approved TAVR devices on a one-year composite endpoint of mortality, stroke and cardiovascular hospitalization.
1. French Regulatory Milestone
Anteris obtained full clearance from France’s National Agency for Medicines and Health Products Safety (ANSM) for its global PARADIGM Trial, authorizing the activation of leading French cardiac centers to enroll patients with severe calcific aortic stenosis into the DurAVR study.
2. Study Design and Objectives
The PARADIGM Trial is a randomized, head-to-head study enrolling approximately 1,000 patients, with participants assigned 1:1 to receive either the DurAVR Transcatheter Heart Valve or an approved commercial TAVR device; the primary endpoint is a composite of all-cause mortality, stroke and cardiovascular hospitalization one year post-procedure.
3. Strategic Impact and Next Steps
France represents a high-volume TAVR market with experienced investigators, and site activations there expand Anteris’ European footprint, support data generation for future regulatory submissions and complement ongoing patient enrollment efforts in the United States and other European regions.
