# Anteris Technologies Wins German Clearance to Enroll PARADIGM Heart Valve Trial

- URL: https://stocks.freetheai.org/news/anteris-technologies-wins-german-clearance-to-enroll-paradigm-heart-valve-trial-d39fc6
- Published: 2026-10-20T01:12:00Z
- Category: company_news; sentiment: bullish; impact: medium
- Symbols: [NASDAQ:AVR](https://stocks.freetheai.org/symbols/NASDAQ-AVR)
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Anteris Technologies Global Corp. (NASDAQ:AVR) has secured full regulatory clearance from Germany's BfArM to start recruiting patients for its global PARADIGM clinical trial. The pivotal study evaluates the company's DurAVR transcatheter heart valve in patients with severe aortic stenosis. Shares of Anteris rose 2.15% to $6.18 following the announcement.

The approval allows German clinical sites to join the trial, expanding the company's footprint into Europe's largest market for transcatheter aortic valve replacement. Gaining access to high-volume medical centers in Germany is expected to support data collection across the trial's planned total of approximately 1,000 randomized participants. The study assesses a primary composite endpoint at one year, measuring non-inferiority regarding death, stroke, and cardiovascular hospitalizations compared to approved devices.

Investors will be monitoring patient enrollment progress across German centers as well as future interim and final trial readouts needed to support regulatory filings.

## Key points

- Anteris Technologies Global Corp. received full BfArM clearance to recruit patients in Germany for its global PARADIGM trial.
- The PARADIGM trial evaluates the DurAVR transcatheter heart valve in approximately 1,000 randomized patients with severe aortic stenosis.
- German trial sites provide access to high-volume medical centers to support patient enrollment and data collection.
- The trial's primary endpoint measures a one-year composite of death, stroke, and cardiovascular hospitalization versus approved TAVRs.

## Questions and answers

### What regulatory approval did Anteris Technologies receive in Germany?

Anteris Technologies received full clearance from Germany's BfArM to begin enrolling patients for its global PARADIGM trial evaluating the DurAVR heart valve.

### What is the goal of the PARADIGM clinical trial?

The trial evaluates the DurAVR heart valve in about 1,000 randomized patients with severe aortic stenosis, measuring a one-year primary composite endpoint of death, stroke, and cardiovascular hospitalization compared to approved devices.

### Why is expanding the trial into Germany important for Anteris?

Germany is Europe's largest market for transcatheter aortic valve replacement, giving Anteris access to high-volume trial centers to help speed patient recruitment.