FDA Approves Anteris’s DurAVR® THV Global Pivotal Trial (the “PARADIGM Trial”)
Anteris Technologies Global Corp. (AVR)
Company Research
Source: GlobeNewswire
PARADIGM: A Prospective rAndomized tRial Assessing the safety and effectiveness of the DurAVR® bIomimetic valve designed for physioloGic flow compared to CoMmercial TAVR devices MINNEAPOLIS and BRISBANE, Australia, Nov. 03, 2025 (GLOBE NEWSWIRE) -- Anteris announced today it has received U.S. Food and Drug Administration (FDA) approval to initiate PARADIGM, its global Investigational Device Exemption (IDE) clinical trial which is designed to evaluate the DurAVR® Transcatheter Heart Valve (THV) in patients with severe calcific aortic stenosis and to support a future PMA* submission. “We are extremely pleased to receive FDA approval for the PARADIGM Trial, which allows us to commence patient recruitment in the United States**. This milestone, together with the recent launch of the trial and first patients treated in Denmark, represents a significant achievement and a key step forward in advancing this life-saving technology worldwide for patients living with aortic stenosis, a debi
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News
- Anteris Technologies Global (NASDAQ:AVR) had its "sell (e+)" rating reaffirmed by analysts at <a style="font-weight:bold" href="https://weissratings.com/">Weiss Ratings</a>.MarketBeat
- Anteris Technologies Presents Data from 100 DurAVR® THV Patients at PCR London ValvesGlobeNewswire
- Anteris Announces Results for the Third Quarter of 2025GlobeNewswire
- Anteris Technologies Global (NASDAQ:AVR) had its "sell (d-)" rating reaffirmed by analysts at <a style="font-weight:bold" href="https://weissratings.com/">Weiss Ratings</a>.MarketBeat
- Anteris DurAVR® THV Demonstrates Favorable Hemodynamics in Small Annuli Patients with no Valve Related Mortality at One YearGlobeNewswire
AVR
Sec Filings
- 12/4/25 - Form 8-K
- 12/1/25 - Form 8-K
- 11/26/25 - Form S-1
- AVR's page on the SEC website