Anteris Commences United States DurAVR THV Early Feasibility Study

August 9, 2023—Anteris Technologies Ltd, an Australia-based structural heart company, announced that an early feasibility study (EFS) of the company’s DurAVR transcatheter heart valve (THV) has commenced enrollment.

According to the company, the DurAVR THV EFS is evaluating the safety and feasibility of the 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 in the United States.

The primary endpoint of the study is device safety and feasibility at 30-days postimplantation. The EFS data will pave the way for a pivotal registrational trial. This is an FDA-designated category B study and approved by the Centers for Medicare & Medicaid for reimbursement, advised the company.

The DurAVR THV EFS Chair is Mike Reardon, Chair of Cardiovascular Research at the Houston Methodist DeBakey Hospital, in Houston, Texas.

The first procedures in the study were performed by national Principal Investigator Azeem Latib, MD, who is Director of Interventional Cardiology, Director of Structural Heart Interventions at Montefiore Health System in New York, New York.

The company reported that the first group of patients with severe AS who were treated with the DurAVR device had intraoperatively postimplantation effective orifice area of 2.2 cm² and average mean gradients of 4 mm Hg.

“Having previously traveled to Europe with Anteris to implant patients with DurAVR THV, I am delighted to note that the postprocedure patient outcomes seen in United States patients at my center corroborate with data reported from previous cohorts,” commented Dr. Latib in Anteris’ press release. “The ability to use this device with such excellent hemodynamic results, as well as ease of use, is incredible progress in the treatment of patients with severe aortic stenosis. We look forward to many more cases in the near future.”

The DurAVR THV is designed to use a single piece of bioengineered tissue. It is made with Anteris’ Adapt anticalcification tissue technology. The biomimetic valve is shaped to mimic the performance of a healthy human aortic valve. The company’s ComAsur delivery system provides controlled deployment and accurate placement of DurAVR, allowing precise alignment with the heart’s native commissures for optimal valve positioning, stated the Anteris press release.