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October 22, 2026
PARADIGM Pivotal Trial of Anteris’ DurAVR THV Cleared in Germany
KEY TAKEAWAYS
- German regulators have authorized the PARADIGM pivotal trial of the DurAVR THV.
- The clearance permits enrollment of patients with severe calcific aortic stenosis at German clinical sites.
- Germany joins the United States and France in supporting the trial’s international enrollment efforts.
October 22, 2026—Anteris Technologies Global Corp. announced that it has received full regulatory clearance from the German Federal Institute for Drugs and Medical Devices to conduct the PARADIGM global pivotal trial of the company’s DurAVR transcatheter heart valve (THV) to treat patients with severe calcific aortic stenosis.
According to the company, the clearance enables Anteris to initiate patient enrollment at leading German centers, which strengthens the trial’s presence in Europe's largest and most established transcatheter aortic valve replacement (TAVR) market and adds scale to the PARADIGM trial.
The PARADIGM trial is a prospective, randomized controlled trial evaluating the safety and effectiveness of the DurAVR THV. It aims to enroll approximately 1,000 patients who will receive either the DurAVR THV or undergo TAVR using commerically available and approved THVs.
In May 2026, Anteris announced commencement of enrollment in the United States. In June 2026, the company announced clearance to conduct the trial in France.
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