Anteris Cleared to Initiate EFS for Transcatheter DurAVR System in United States

November 28, 2022—Anteris Technologies Ltd. announced the FDA has conditionally approved an investigational device exemption (IDE) to commence an early feasibility study (EFS) in the United States for the company’s DurAVR transcatheter heart valve (THV) replacement system.

The DurAVR is a balloon-expandable, three-dimensional, single-piece aortic valve that is shaped to mimic the native human valve. It is an investigational device, limited by federal law for investigational use only. The FDA has categorized DurAVR in this study as a Centers for Medicare and Medicaid Services (CMS) Category B device, which permits the device to be sold during the study pending CMS approval, advised the company.

According to Anteris, the EFS will evaluate the safety and feasibility of the DurAVR device in the treatment of patients with symptomatic severe native aortic stenosis (AS). The study will enroll 15 patients at seven heart valve centers of excellence within the United States. It is anticipated the study will commence in early 2023 and lead to a pivotal registration AS trial in the first half of 2024.

Anteris advised that this trial’s primary and key secondary endpoints include safety and device feasibility assessments such as success of implantation at the anatomically accurate position and hemodynamic performance assessments (ie, 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, 3 months, and 1 year postimplantation.

Michael Reardon, MD, is study chair for the EFS. Dr. Reardon is Allison Family Distinguished Chair in Cardiovascular Research, Department of Cardiovascular Surgery, Professor of Cardiovascular Surgery, Houston Methodist Hospital, in Houston, Texas.

“I am pleased and eager to begin the DurAVR THV EFS to further evaluate this promising novel technology,” commented Dr. Reardon in the company’s press release. “The single-piece, native-shape valve design of the DurAVR THV represents an advancement to existing heart valve technologies. I am excited to see the potential of the DurAVR THV in treating patients suffering from severe aortic stenosis.”