The company, which was founded in Australia and has a U.S. presence in Minneapolis, said its PARADIGM trial evaluates the DurAVR transcatheter heart valve (THV) head-to-head against transcatheter aortic valve replacement (TAVR) using commercially available and approved THVs in patients with severe calcific aortic stenosis.
Anteris designed TurAVR THV as a new class of biomimetic heart valve. The company — one of MassDevice’s 5 next-gen heart valve replacement companies you need to know — says it’s the world’s only balloon-expandable, single-piece transcatheter aortic valve shaped to mimic a native human aortic valve’s performance. Balloon-expandable delivery enables precise alignment with the heart’s native commissures, achieving desired valve positioning.
(Learn more about transcatheter heart valves in MassDevice’s Transcatheter Heart Valves Special Report. Go here to download the report for free.)
The company reported a first successful implant of the valve in 2023 and launched an IPO in late 2024 to further advance its development.
Earlier this year, medtech giant Medtronic agreed to invest up to $90 million in Anteris and its technology, striking a deal to acquire a 16%-19.99% stake.
Now, Anteris continues to proceed with its clinical evaluation of the heart valve technology. PARADIGM, a prospective, randomized controlled trial, will enroll approximately 1,000 patients in the “all comers randomized cohort.” Investigators plan to randomize patients 1:1 to either DurAVR therapy or TAVR with available THVs. The study assesses non-inferiority on a primary composite endpoint of all-cause mortality, all stroke and cardiovascular hospitalization at one year post procedure.
Dr. Azeem Latib performed the initial procedures in the study of DurAVR at Montefiore Medical Center in New York.
Commentary from Anteris officials and investigators
Wayne Paterson, vice chair and CEO of Anteris, said:
“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 U.S. study sites come on line and expand recruitment capability.”
Dr. Latib, the principal investigator for PARADIGM, added:
“Performing the first U.S. 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. 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.”
