Anteris (AVR) announced it has received FDA approval to initiate PARADIGM, its global Investigational Device Exemption clinical trial which is designed to evaluate the DurAVR Transcatheter Heart Valve in patients with severe calcific aortic stenosis and to support a future PMA submission.
The company noted that the PARADIGM Trial is designed to provide the clinical evidence required to support an application to the FDA for Premarket Approval in the United States, with CE Mark approval anticipated to progress in parallel to the PMA.
Shares of Anteris are up 3% in pre-market trade on Monday.
For More Such Health News, visit rttnews.com.
For comments and feedback contact: editorial@rttnews.com
May 22, 2026 14:46 ET Minutes of the latest Fed policy session was the highlight of the week along with survey data on the U.S. housing market. In Europe, survey data signaled the trends in the euro area private sector. Further, consumer price inflation data from the U.K. was in focus. In Asia, various economic indicators from China drew attention to the health of the economy.