Anteris Technologies (ASX:AVR) received US Food and Drug Administration approval to start its Paradigm clinical trial evaluating the DurAVR transcatheter heart valve (THV) in patients with severe calcific aortic stenosis, according to a Monday filing with the Australian bourse.

Calcific aortic stenosis is a progressive heart condition where calcium deposits on the aortic valve, causing it to thicken and narrow, obstructing blood flow.

The trial will evaluate the company's DurAVR THV against commercially available transcatheter aortic valve replacements and supports a future pre-market approval application to the US FDA, per the filing.

Shares rose 11% in afternoon trade Monday.