Anteris Technologies announced that it received full regulatory clearance to expand its PARADIGM trial to France.
The company – founded in Brisbane, Australia with a U.S. presence in Minneapolis – earned the green light from the French National Agency for Medicines and Health Products Safety (ANSM) to bring the global pivotal trial of its DurAVR transcatheter heart valve (THV) for patients with severe calcific aortic stenosis to France.
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Anteris said the clearance marks a significant milestone in its clinical and regulatory strategy. Approval enables patient recruitment to commence at leading French centers as PARADIGM enrollment continues across the U.S. and Europe.
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.
Anteris announced the first patients enrolled and successfully treated in the trial last month.
“Securing French regulatory clearance is an important step in the execution of the PARADIGM Trial,” said Wayne Paterson, Anteris vice chair and CEO. “France represents a strategically important market with highly experienced centers and investigators, reinforcing the quality and conduct of the study.”
Anteris designed DurAVR 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.
The company reported a first successful implant of the valve in 2023. It 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. The agreement included a deal to acquire a 16%-19.99% stake.
