Anteris secures German clearance for 1,000-patient trial

• Anteris Technologies Global received full authorization from Germany's Federal Institute for Drugs and Medical Devices (BfArM) to recruit patients for its pivotal PARADIGM heart valve trial.
• The randomized study will enroll approximately 1,000 patients, comparing DurAVR with approved transcatheter heart valves on mortality, stroke and cardiovascular hospitalization after one year.
• Anteris expects German clinical centers to expand patient access and accelerate enrollment, supporting its international development program for DurAVR.

Anteris Technologies Global (NASDAQ:AVR) received full German regulatory clearance to recruit patients for its global PARADIGM trial evaluating the DurAVR heart valve.

The authorization expands the trial's European reach, although it permits clinical recruitment rather than commercial approval of the investigational valve.

“Germany’s scale, clinical expertise and established TAVR infrastructure create an important opportunity to advance enrollment,” said Anteris Vice Chairman and Chief Executive Officer Wayne Paterson.

The randomized study will enroll approximately 1,000 patients, comparing DurAVR against approved valves on death, stroke and cardiovascular hospitalization at one year.

Anteris expects German site activation to accelerate recruitment, although the company has not disclosed a new enrollment completion forecast or financial impact.

PARADIGM uses equal randomization between treatment groups and will assess whether DurAVR performs no worse than approved transcatheter valves within a predefined margin.

Anteris previously secured trial clearances in Denmark, France and the United States, advancing development of its balloon-expandable DurAVR valve for severe aortic stenosis.