Anteris Announces Results From Second ViV Procedure With DurAVR THV

August 14, 2023—Anteris Technologies Ltd, announced results from a second successful valve-in-valve (ViV) implantation with the company’s DurAVR transcatheter heart valve (THV). The balloon-expandable, single-piece DurAVR THV is a new class of biomimetic heart valve.

According to the company, the procedure was performed as part of Health Canada’s Special Access Program (SAP), which exists so that life-saving technology not currently available for commercial use in Canada can be provided when no other commercially available alternatives are suitable.

Janar Sathananthan, MBChB, an interventional cardiologist at Vancouver General and St. Paul’s Hospital in Vancouver, Canada, made the request to Health Canada to make DurAVR THV available for this procedure. Dr. Sathananthan is a world expert on bench testing the hemodynamic effects of different valves used in ViV procedures, noted the company.

On July 31, Anteris announced that the first ViV procedure with the DurAVR THV was performed successfully under the SAP by Anita Asgar, MD, Codirector of the Structural Heart Program at the Institut de Cardiologie de Montreal in Montreal, Canada.

In the procedure by Dr. Sathananthan, the DurAVR THV was implanted in a female patient (aged 79 years) who was previously implanted with a Trifecta surgical valve (Abbott) that had severely degenerated, causing debilitating symptoms. The intraoperative results after implantation of the DurAVR THV included a mean pressure gradient of 7 mm Hg, restoring near-normal physiology. The patient was safely discharged < 24 hours after the procedure, reported the company.

“DurAVR THV performed exceptionally well during this complex ViV procedure,” commented Dr. Sathananthan in Anteris’ press release. “Today’s case demonstrated what we saw in preclinical testing, that DurAVR THV has the potential to offer superior gradients for ViV patients. This is a great result in a small surgical valve at high risk for elevated gradients.”

The company advised that the DurAVR THV is being investigated for severe aortic stenosis patients in two early feasibility studies (EFSs) being conducted in Europe (a first-in-human study) and the United States (DurAVR EFS). On August 9, Anteris announced the commencement of enrollment in the United States DurAVR EFS.