First Patients Treated in Global PARADIGM Trial: Anteris Technologies Targets Aortic Stenosis with Innovative DurAVR THV System
PARADIGM Trial Kicks Off with Promising Early Results in Europe
In a major step for structural heart disease innovation, Anteris Technologies has announced the successful treatment of the first patients in its pivotal PARADIGM Trial evaluating the DurAVR® Transcatheter Heart Valve (THV). This randomized global trial aims to assess DurAVR®'s safety and effectiveness for severe calcific aortic stenosis, with the first procedures performed by Prof. Dr. Ole De Backer at The Heart Center, Rigshospitalet, Copenhagen University Hospital in Denmark.
Direct Comparison to Commercial TAVR: The Heart of the PARADIGM Trial
What sets this trial apart? The PARADIGM Trial is enrolling approximately 1,000 patients worldwide, directly comparing DurAVR® THV against existing transcatheter aortic valve replacement (TAVR) solutions. Participants are randomly assigned in a 1:1 ratio to receive either DurAVR® or another FDA- and CE-cleared valve. The main focus: measuring non-inferiority based on all-cause mortality, all stroke, and cardiovascular hospitalizations one year after treatment—a rigorous endpoint for cardiac innovation.
| Trial Feature | Detail |
|---|---|
| Enrollment Target | ~1,000 patients |
| Randomization Ratio | 1:1 (DurAVR® THV vs. Commercial TAVR) |
| Primary Endpoint | Composite of all-cause mortality, all stroke, and cardiovascular hospitalization at 1 year |
| Geographies | United States, Europe, Canada (planned expansion) |
DurAVR® THV’s Unique Biomimetic Design Could Shift Clinical Practice
The DurAVR® valve stands out for its biomimetic engineering—designed to replicate the performance and flow of a healthy aortic valve. Constructed with ADAPT® tissue, a patented anti-calcification technology already used in over 55,000 patients globally, the device aims to combine durability and natural function. The positive early feedback from clinicians, according to Prof. Dr. De Backer, adds momentum to expectations that DurAVR® could transform outcomes for patients with both straightforward and complex valve disease, such as those with bicuspid anatomies or in valve-in-valve scenarios.
Expansion Plans and Strong Clinical Momentum
Anteris is moving quickly to broaden the trial’s reach, with expansion into North America and additional international sites anticipated. To date, the company's previous data includes over 130 successfully treated cases, underpinning confidence in rapid enrollment and the trial’s advancement.
| DurAVR® At-a-Glance | Key Details |
|---|---|
| Platform | Biomimetic balloon-expandable valve, ADAPT® tissue |
| Intended Use | Severe calcific aortic stenosis (including de novo, ViV, and bicuspid patients) |
| Prior Clinical Cases | 130+ patients worldwide |
| FDA-Cleared Tissue | ADAPT® used in >55,000 patients |
What This Means for the Future of Heart Valve Therapy
This large-scale, prospective study represents the highest standard of clinical evidence—critical for U.S. FDA Premarket Approval and wider adoption. By directly challenging established competitors on outcomes, Anteris is betting its DurAVR® THV will not only prove non-inferiority but potentially establish new benchmarks in patient recovery and long-term heart health.
The PARADIGM Trial is poised to answer key questions for cardiologists and patients alike: can biomimetic tissue valves deliver better, longer-lasting outcomes with reduced risk? Investors and clinicians will be watching closely as new cohorts are added and comparative data rolls in. The potential impact—expanding safe, effective treatment to a broader range of aortic stenosis patients—makes this a pivotal moment in the field.
Where to Find More Information
For trial updates, clinical data, and contact information, visit the Anteris Technologies website or the official ClinicalTrials.gov listing (ID: NCT07194265).
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