Anteris Technologies Ltd. reported that DurAVR? THV, a new class of biomimetic heart valve and the only balloon-expandable, single-piece transcatheter aortic valve was implanted in a second successful Valve-in-Valve (ViV) procedure as part of Health Canada?s Special Access Program (SAP). A ViV procedure is required for patients with a life-threatening situation wherein their current bioprosthetic aortic valve is failing due to calcification or structural deterioration, and a new heart valve must be implanted inside the failing valve.

These patients are at high risk for another surgery and require a minimally invasive treatment option. Currently available commercial products can leave patients with a high risk of remaining in a diseased state post-procedure, with unsatisfactory high gradients. Canada?s SAP 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.

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

THV was implanted in a 79-year-old female who was previously implanted with a Trifecta surgical valve that had severely degenerated, causing debilitating symptoms. The intraoperative results after DurAVR? THV was implanted were phenomenal, with a mean pressure gradient of 7mmHg, restoring near-normal physiology. The patient was safely discharged less than 24 hours after the procedure.

DurAVR? THV continues to be investigated in a clinical trial setting for severe aortic stenosis patients in two Early Feasibility Studies (EFS) being run in the US and Europe at this time.