Anteris Technologies has announced it has received US Food and Drug Administration (FDA) approval to initiate PARADIGM, a global investigational device exemption (IDE) clinical trial which is designed to evaluate the DurAVR transcatheter heart valve (THV) in patients with severe calcific aortic stenosis and to support a future premarket approval (PMA) submission.
“We are extremely pleased to receive FDA approval for the PARADIGM trial, which allows us to commence patient recruitment in the USA. This milestone, together with the recent launch of the trial and first patients treated in Denmark, represents a significant achievement and a key step forward in advancing this life-saving technology worldwide for patients living with aortic stenosis, a debilitating and progressive condition,” commented Wayne Paterson, vice chairman and chief executive officer, Anteris Technologies.
The PARADIGM trial is co-chaired by Michael J Reardon (Houston Methodist Hospital, Houston, USA) and Stephan Windecker (Bern University Hospital, Bern, Switzerland).
The PARADIGM trial is a prospective randomised controlled trial (RCT) which will evaluate the safety and effectiveness of the DurAVR THV compared to commercially available transcatheter aortic valve implantation (TAVI) systems.
The head-to-head study will enrol 1,000 patients across the USA, Europe and Canada 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 PARADIGM trial will assess non-inferiority on a primary composite endpoint of all-cause mortality, all stroke and cardiovascular hospitalisation at one year post procedure.
