Anteris Launches Global Trial for Innovative DurAVR Heart Valve
Anteris Technologies has secured its first European regulatory clearance to commence the global PARADIGM Trial for its DurAVR Transcatheter Heart Valve, marking a significant step toward worldwide commercialization.
- Danish Medicines Agency approves start of PARADIGM Trial
- Patient recruitment to begin in Denmark Q4 2025
- Trial compares DurAVR THV to existing commercial TAVR devices
- Planned expansion to US, Europe, and Canada
- FDA IDE application under review, approval expected soon
Regulatory Milestone Achieved
Anteris Technologies Global Corp. has taken a pivotal step forward by receiving regulatory clearance from the Danish Medicines Agency to initiate its global PARADIGM Trial. This trial will evaluate the safety and effectiveness of the company’s DurAVR Transcatheter Heart Valve (THV) in patients suffering from severe calcific aortic stenosis, a condition characterized by the narrowing of the aortic valve that can severely impair heart function.
Patient recruitment at Danish centers is slated to begin in the fourth quarter of 2025, setting the stage for what Anteris describes as a landmark study designed with input from leading cardiologists and cardiac surgeons worldwide.
The PARADIGM Trial – A Global Endeavor
The PARADIGM Trial is a prospective, randomized controlled study comparing the DurAVR THV against commercially available transcatheter aortic valve replacements (TAVRs). Approximately 1,000 patients will be enrolled in an 'All Comers Randomized Cohort,' with participants randomly assigned to receive either the DurAVR valve or a competitor device. The primary endpoint focuses on a composite measure of all-cause mortality, stroke, and cardiovascular hospitalization one year after the procedure.
With the initial European clearance secured, Anteris plans to expand the trial across the United States, Europe, and Canada. The company is optimistic that strong investigator interest will facilitate efficient patient recruitment and timely progression of the study.
Innovative Technology with Commercial Potential
The DurAVR THV stands out as the first biomimetic valve designed to replicate the natural flow dynamics of a healthy human aortic valve. Made from Anteris’ patented ADAPT tissue technology, which has been FDA-cleared and used in over 55,000 patients globally, the valve aims to improve hemodynamic performance and patient outcomes.
Executives at Anteris emphasize that the PARADIGM Trial is not only a clinical milestone but also a critical step toward obtaining multiple regulatory approvals, including Premarket Approval (PMA) in the US and CE Mark in Europe. These approvals would pave the way for commercial launch and broader patient access worldwide.
Awaiting US FDA Approval
While the Danish clearance marks a significant achievement, the trial’s expansion into the US hinges on the approval of an Investigational Device Exemption (IDE) application currently under review by the U.S. Food and Drug Administration (FDA). Anteris expects this approval in the near term, which would allow the initiation of study sites across the United States pending institutional review board approvals.
Overall, the PARADIGM Trial represents a watershed moment for Anteris, signaling the transition from development to commercialization planning for its innovative heart valve technology.
Bottom Line?
As Anteris moves forward with its global trial, all eyes will be on FDA approval and early clinical data to validate the promise of its biomimetic heart valve.
Questions in the middle?
- When will the FDA grant IDE approval to enable US trial sites?
- How quickly can patient recruitment scale beyond Denmark?
- What interim clinical data might emerge to influence regulatory decisions?
