DurAVR Trial FDA Approval Raises Stakes in Competitive Heart Valve Market
Anteris Technologies has secured FDA approval to commence its pivotal PARADIGM clinical trial, testing its innovative DurAVR Transcatheter Heart Valve against established devices in patients with severe aortic stenosis.
- FDA approval granted to start PARADIGM global pivotal trial
- Trial to enroll ~1000 patients across US, Europe, and Canada
- DurAVR THV compared head-to-head with commercial TAVR devices
- Primary endpoint includes mortality, stroke, and cardiovascular hospitalization
- Trial data to support future FDA Premarket Approval and CE Mark applications
FDA Approval Marks Major Milestone for Anteris
Anteris Technologies Global Corp. has received a critical green light from the U.S. Food and Drug Administration (FDA) to initiate its PARADIGM Trial, a global clinical study designed to evaluate the safety and effectiveness of its DurAVR Transcatheter Heart Valve (THV). This approval allows Anteris to begin patient recruitment in the United States, complementing recent trial launches in Europe.
A Rigorous Head-to-Head Clinical Study
The PARADIGM Trial is a prospective, randomized controlled trial enrolling approximately 1000 patients across the United States, Europe, and Canada. It pits the DurAVR THV directly against commercially available transcatheter aortic valve replacement (TAVR) devices. Patients will be randomized 1 – 1 to receive either the DurAVR valve or an approved TAVR device, with the study’s primary composite endpoint focusing on all-cause mortality, stroke, and cardiovascular hospitalizations at one year post-procedure.
Innovative Biomimetic Valve Technology
DurAVR is distinguished by its biomimetic design, engineered to replicate the natural flow dynamics of a healthy human aortic valve. Made from Anteris’ patented ADAPT tissue, a single molded piece of anti-calcification material with over a decade of clinical use, the valve aims to improve patient outcomes by reducing complications commonly associated with calcific aortic stenosis. The balloon-expandable valve system is the company’s flagship product and represents a significant advancement in structural heart disease treatment.
Global Leadership and Regulatory Strategy
The trial is co-chaired by leading cardiovascular experts from Houston Methodist Hospital and Bern University Hospital, underscoring the study’s international scope and scientific rigor. The data generated will form the cornerstone of Anteris’ Premarket Approval (PMA) submission to the FDA, a stringent regulatory pathway requiring high-level clinical evidence. Parallel efforts are underway to secure CE Mark approval in Europe, positioning DurAVR for broader market access.
Looking Ahead
With patient enrollment underway and the trial progressing, Anteris is poised to deliver pivotal clinical data that could reshape the competitive landscape of transcatheter heart valve therapies. The company’s commitment to innovation and robust evidence generation will be closely watched by investors and clinicians alike as the PARADIGM Trial unfolds.
Bottom Line?
Anteris’ FDA approval to start PARADIGM sets the stage for a potential breakthrough in heart valve therapy.
Questions in the middle?
- How quickly will patient enrollment progress across multiple regions?
- What interim data might hint at DurAVR’s comparative performance?
- How will Anteris position DurAVR against entrenched TAVR competitors post-trial?
