Anteris Technologies Pty Ltd (ASX:AVR, NASDAQ:AVR) has enrolled and successfully treated the first US patients in the global pivotal trial of its DurAVR® Transcatheter Heart Valve (THV) for severe calcific aortic stenosis.
The procedures were carried out by Dr Azeem Latib at Montefiore Medical Center in New York.
“Following CMS approval, the Anteris team and our physician partners worked closely together to achieve first patient enrolments within the week. This marks a major milestone for the PARADIGM Trial as our US study sites come on line and expand recruitment capability,” Anteris vice chairman and CEO Wayne Paterson said.
The PARADIGM Trial is designed to assess DurAVR THV, Anteris’ transcatheter heart valve technology, in patients with severe calcific aortic stenosis.
“Performing the first US cases in the global PARADIGM Trial is a significant achievement for trial investigators, and our early procedural experience with the DurAVR® THV System has been highly encouraging,” Principal Investigator and Director of Interventional Cardiology and Director of Structural Heart Interventions at Montefiore, Dr. Latib said.
“PARADIGM is specifically designed to answer clinically meaningful questions and go beyond the usual safety metrics and hemodynamics by also looking at the impact of flow patterns on left ventricular recovery. Initiating enrollment represents a critical step toward generating the evidence needed to inform future patient care.”
US Medicare coverage for PARADIGM trial procedures
Last week, Anteris secured US Medicare reimbursement eligibility for procedures conducted under its global pivotal PARADIGM Trial.
The PARADIGM Trial is a prospective, randomised controlled study designed to evaluate the safety and effectiveness of the company’s DurAVR® Transcatheter Heart Valve against commercially available transcatheter aortic valve replacement (TAVR) devices.
The head-to-head study is expected to enrol around 1,000 patients in its All Comers Randomized Cohort, with participants assigned on a 1:1 basis to receive either the DurAVR THV or an approved commercial valve.
The trial will assess non-inferiority based on a primary composite endpoint of all-cause mortality, stroke and cardiovascular hospitalisation at 1 year post-procedure.
Anteris said eligible procedures at participating US study sites will be reimbursed under the Centers for Medicare & Medicaid Services’ Transcatheter Aortic Valve Replacement National Coverage Determination 20.32.
The framework operates under a Coverage with Evidence Development model, allowing reimbursement while clinical data is generated through the trial.