Anteris Technologies Ltd (ASX:AVR, OTC:AMEUF) CEO Wayne Paterson discusses with Proactive the news that the US Food and Drug Administration (FDA) has conditionally approved the DurAVR™ transcatheter heart valve (THV) system for investigational device exemption (IDE) application to kick off an early feasibility study (EFS). The study will evaluate the safety and feasibility of the DurAVR™ THV System in the treatment of subjects with symptomatic severe native aortic stenosis.
Anteris Technologies hails FDA early feasibility study approval for DurAVR™