Dec. 10 at 3:54 PM
Anteris Technologies (NASDAQ:
$AVR) secured FDA IDE clearance to launch PARADIGM, a ~1,000‑patient global pivotal trial pitting its biomimetic DurAVR THV head‑to‑head against commercial TAVR valves in severe calcific aortic stenosis, aiming at future U.S. PMA and CE Mark approvals.
https://prismmarketview.com/anteris-technologies-receives-fda-clearance-to-launch-global-pivotal-trial-for-duravr-heart-valve/