Anteris Technologies Ltd. announced the U.S. Food and Drug Administration (FDA) has conditionally approved the DurAVR Transcatheter Heart Valve (THV) System for investigational device exemption (IDE) application to commence 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. The FDA concluded the Company provided adequate data to support the initiation of a clinical study in the United States.

The EFS will enroll 15 subjects at 7 Heart Valve Centers of Excellence within the United States. It is anticipated the study will commence in early 2023. The FDA has categorized DurAVR in this study as a CMS Category B device, which permits the device to be sold during the study pending CMS approval.

DurAVR THV System is an investigational device, limited by federal law for investigational use only.