28 November 2022 - - The US Food and Drug Administration has conditionally approved Australia-based structural heart company Anteris Technologies Ltd's (ASX: AVR) DurAVR Transcatheter Heart Valve (THV; TAVR) System for investigational device exemption application to commence an Early Feasibility Study, the company said.

The EFS study will evaluate the safety and feasibility of DurAVR 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, paving the way for a pivotal, registration AS trial in 1H2024.

The primary and key secondary endpoints of this trial include safety and device feasibility assessments such as success of implantation at the anatomically accurate position, and hemodynamic performance assessments including effective orifice area, mean gradient, aortic regurgitation, paravalvular leak and Doppler Velocity Index.

Patient outcomes such as stroke, myocardial infarction, life-threatening bleeds, and all-cause mortality are to be reported at 30 days, three-months, and one-year post implantation.

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.

Anteris Technologies Ltd (ASX: AVR) is a structural heart company.

Anteris is focused on developing next-generation technologies that help healthcare professionals deliver consistent, life-changing outcomes for patients.

Anteris' DurAVR 3D, single-piece, aortic heart valve replacement addresses the needs of today's younger and more active aortic stenosis patients by delivering superior performance and durability through innovations designed to last the remainder of a patient's lifetime.

The proven benefits of Anteris' patented ADAPT tissue technology, paired with the unique design of our DurAVR 3D, single-piece, aortic heart valve, have the potential to deliver a game-changing treatment to aortic stenosis patients worldwide and provide a much-needed solution to the challenges facing doctors.