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Anteris Technologies Global Corp. (Anteris), a global structural heart company committed to designing, developing, and commercializing cutting-edge medical devices to restore healthy heart function, announced that the first patients in the United States have been enrolled and successfully treated in the DurAVR Transcatheter Heart Valve (THV) global pivotal trial for patients with severe calcific aortic stenosis (the PARADIGM Trial). The procedures were performed by Azeem Latib, M.D. at Montefiore Medical Center, New York, United States.
"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," said Dr. Latib, principal investigator and director of interventional cardiology and director of structural heart interventions at Montefiore. "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."
"Following CMS approval, the Anteris team and our physician partners worked closely together to achieve first patient enrollments within the week. This marks a major milestone for the PARADIGM Trial as our US study sites come on line and expand recruitment capability," said Wayne Paterson, vice chairman and chief executive officer of Anteris.
The PARADIGM Trial is a prospective randomized controlled trial which will evaluate the safety and effectiveness of the DurAVR THV compared to commercially available transcatheter aortic valve replacements (TAVRs).
This head-to-head study will enroll approximately 1000 patients in the ‘All Comers Randomized Cohort' with 1:1 randomization of patients who will receive either the DurAVR THV or TAVR using commercially available and approved THVs. The PARADIGM Trial will assess non-inferiority on a primary composite endpoint of all-cause mortality, all stroke and cardiovascular hospitalization at one year post procedure.
Anteris Technologies Global Corp. is a global structural heart company committed to designing, developing, and commercializing cutting-edge medical devices to restore healthy heart function. Founded in Australia, with a significant presence in Minneapolis, USA, Anteris is a science-driven company with an experienced team of multidisciplinary professionals delivering restorative solutions to structural heart disease patients.
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