Anteris announced 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 debilitating and progressive condition,” commented Vice Chairman and CEO, Wayne Paterson.
TipRanks Cyber Monday Sale
- Claim 60% off TipRanks Premium for data-backed insights and research tools you need to invest with confidence.
- Subscribe to TipRanks' Smart Investor Picks and see our data in action through our high-performing model portfolio - now also 60% off
Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>>
Read More on AVR:
- Promising Investment Opportunity: Anteris Technologies’ DurAVR Platform Showcases Outstanding Clinical Outcomes
- Anteris Technologies reports clinical outcomes for DurAVR THV in patients
- Anteris Technologies Begins Global PARADIGM Trial Enrollment
- Anteris Technologies treats first patient in DurAVR heart valve pivotal trial
- Anteris Technologies Raises $11.5M in Stock Offering