Anteris Technologies Ltd, a structural heart company developing DurAVR™ THV, a new class of biomimetic heart valve and the world’s only balloon-expandable, single-piece transcatheter aortic valve shaped to mimic the performance of a native human aortic valve, announces that the DurAVR™ THV was used for the first time in a 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. 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. Anita Asgar, Co-Director of the Structural Heart Program at the Institut de Cardiologie de Montreal (Montreal, Canada), made the request to Health Canada to use the DurAVR™ THV in a patient with a failing valve that needed optimal hemodynamic results as well as a short frame height as they were very high risk of poor hemodynamic result with a conventional ViV procedure. Dr. Asgar performed the procedure on an 84-year-old male and implanted a DurAVR™ THV inside the failed surgical aortic valve replacement (SAVR).

The procedure was successful. The hemodynamic performance of the valve was outstanding in such a complex patient. The patient had an 88% reduction in mean gradient which brought the patient back to a near-normal physiologic state, with a final gradient of only 6mmHg after deploying the valve. These results mirror what DurAVR™ THV has seen in its extensive ViV bench-top studies.

Dr. Asgar commented:

“The DurAVR™ THV provided a life-saving solution for a patient requiring a new valve to be implanted without compromising hemodynamic performance or future coronary access. These hemodynamic results are not seen with currently available products, which is important as there is a large need for a valve that can offer optimal hemodynamic performance in the valve-in-valve setting, particularly with a shorter frame height. Additionally, despite this being an incredibly complex case, using Anteris’ ComASUR™ delivery system and deploying the valve was remarkably easy. The unique design of DurAVR™, including the low frame height and the single-piece design, makes the valve well-suited to address the needs of valve-in-valve patients.”

Chris Meduri, Anteris Technologies CMO, commented:

“This successful procedure further validates our extensive pre-clinical work in valve-in-valve as well as our extensive clinical experience in native aortic stenosis. This signals the viability of a purpose-built valve designed to achieve life-saving outcomes in a patient population currently treated with tradeoffs in mind. Eliminating that compromise would be widely beneficial to a rapidly growing population of patients whose current valve is failing.”

 

Source:businesswire.com

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