(RTTNews) - 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.
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