Anteris Technologies has received full regulatory clearance from the German Federal Institute for Drugs and Medical Devices (BfArM) for the DurAVR transcatheter heart valve (THV) global pivotal trial for patients with severe calcific aortic stenosis—the PARADIGM trial—patient recruitment at leading German centres and represents an important step in expanding the PARADIGM trial’s European footprint.
PARADIGM is a prospective randomised controlled trial which will evaluate the safety and effectiveness of the DurAVR valve compared to commercially available transcatheter aortic valve implantation (TAVI) systems.
The head-to-head study will enrol approximately 1,000 patients in the ‘all comers randomised cohort’ with 1:1 randomisation of patients who will receive either the DurAVR THV or TAVI using commercially available and approved THVs. The trial will assess non-inferiority on a primary composite endpoint of all-cause mortality, all stroke and cardiovascular hospitalisation at one year post procedure.
“Germany’s scale, clinical expertise and established TAVI infrastructure create an important opportunity to advance enrolment and extend PARADIGM’s reach across leading international TAVI markets,” said Wayne Paterson, vice chairman and CEO of Anteris.
