The flagship transcatheter heart valve of Anteris Technologies Ltd (ASX:AVR, OTC:AMEUF) has been successfully implanted during a valve-in-valve procedure as part of Health Canada’s Special Access Program (SAP).
The procedure is used in life-threatening situations where a patient’s bioprosthetic aortic valve is failing due to calcification or structural deterioration, meaning a new heart valve must be implanted inside the failing valve.
These patients are typically at high risk for another surgery and require a minimally invasive treatment option, making Anteris’ DurAVR™ heart valve an attractive candidate for these kinds of procedures.
Canada’s SAP exists so life-saving technology that’s not currently available for commercial use can be provided when no other commercially available alternatives are suitable.
The procedure
Dr Anita Asgar, co-director of the Structural Heart Program at the Institut de Cardiologie de Montreal, asked to use the DurAVR valve given the need for optimal hemodynamic results.
The medical team was also contending with the patient’s short frame height, meaning there was very high risk of poor hemodynamic performance with a conventional valve-in-valve procedure.
Dr Asgar performed the surgery on an 84-year-old male and implanted a DurAVR™ THV inside the failed surgical aortic valve replacement.
Positively, Anteris reported the hemodynamic performance of its DurAVR valve was outstanding in such a complex patient, mirroring what has been seen in extensive valve-in-valve bench-top studies.
Technically speaking, the patient saw an 88% reduction in mean gradient, bringing them back to a near-normal physiologic state with a final gradient of only 6mmHg (a measurement of pressure) after the valve was deployed.
“Hemodynamic results not seen with currently available products”
Following the surgery, Dr Asgar said DurAVR provided a life-saving solution for the patient, who needed a new heart valve that didn’t compromise 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,” she explained.
Despite this being an incredibly complex case, Dr Asgar said 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,” she concluded.
Anteris’ ComASUR system is a balloon-expandable device that deploys the DurAVR valve precisely and accurately.
It helps surgeons align the device with the heart’s native commissures, meaning they can achieve ideal valve positioning in potentially life-saving procedures.
Eliminating compromise
Anteris CEO Chris Meduri said the successful procedure further validated the company’s extensive pre-clinical valve-in-valve work, as well as its 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 trade-offs in mind,” he described.
“Eliminating that compromise would be widely beneficial to a rapidly growing population of patients whose current valve is failing.”