Anteris Technologies enrolls First US patients in global PARADIGM trial for DurAVR heart valve

Anteris Technologies CEO Wayne Paterson joined Steve Darling from Proactive to announce that the company has reached a major milestone by enrolling and treating the first patients in the United States for its DurAVR Transcatheter Heart Valve global pivotal trial. These landmark procedures were conducted at the Montefiore Medical Center in New York and were specifically performed for patients diagnosed with severe calcific aortic stenosis. Paterson noted during the announcement that conducting these initial U.S. cases within the global PARADIGM Trial represents a significant achievement for the investigators involved and offers valuable early procedural experience with the DurAVR THV System. The PARADIGM Trial is uniquely designed to address clinically meaningful questions that extend beyond standard safety metrics and basic hemodynamics. One of its core research objectives is to evaluate the specific impact of valve flow patterns on left ventricular recovery. According to the company, initiating this enrollment phase is a critical step in generating the high-quality evidence required to shape future standards of patient care. As a prospective randomized controlled trial, the study is set to evaluate the safety and clinical effectiveness of the DurAVR THV in direct comparison to various commercially available transcatheter aortic valve replacements currently on the market. The trial is expected to enroll approximately 1,000 patients into its 'All Comers Randomized Cohort'. Through a 1:1 randomization protocol, participants will be assigned to receive either the DurAVR THV or a standard TAVR using currently approved, commercially available heart valves. Ultimately, the trial investigators will assess non-inferiority based on a primary composite endpoint that tracks all-cause mortality, all instances of stroke, and cardiovascular-related hospitalizations exactly one year after the procedure has been completed. #proactiveinvestors #anteristechnologiesglobalcorp #asx #avr #nasdaq #avr #DurAVR #TAVR #HeartValve #ClinicalTrials #Cardiology #AorticStenosis #MedicalDevice #HealthcareInnovation #PARADIGMTrial #Biotech #MedTech #PatientCare #FDA #Cardiovascular