Anteris Technologies’ DurAVR THV Used for First Time in a Valve-in-Valve Procedure

Anteris Technologies Ltd. is marking the first clinical use of DurAVR THV, a new class of biomimetic valve and the world’s only balloon-expandable, single-piece transcatheter aortic valve, 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 lifesaving technology not currently available for commercial use in Canada can be provided when there are no other commercially available alternatives are suitable. ViV procedures increased more than 10-fold from 2014 to 2019, representing about 6% of U.S. commercial transcatheter aortic valve replacement cases.¹ 

DurAVR is a transcatheter heart valve (THV) used to treat aortic stenosis. DurAVR THV has been designed in partnership with the world’s leading interventional cardiologists and cardiac surgeons and is the first transcatheter aortic valve replacement (TAVR) to use a single piece of bioengineered tissue. This biomimetic valve is uniquely shaped to mimic the performance of a healthy human aortic valve. DurAVR is made using ADAPT tissue, Anteris’ patented anti-calcification tissue technology that has been used clinically for more than 10 years in over 50,000 patients worldwide.
 
Controlled deployment and accurate placement of DurAVR THV is conducted through Anteris’ proprietary ComASUR Delivery System, which allows for precise alignment with the heart’s native commissures to achieve optimal valve positioning.
 
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 there was very high risk of poor hemodynamic performance with a conventional ViV procedure. Asgar performed the procedure on an 84-year-old male and implanted a DurAVR THV inside the failed surgical aortic valve replacement (SAVR).

“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,” Asgar said. “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 design of DurAVR, including the low frame height and the singlepiece design, makes the valve well-suited to address the needs of valve-in-valve patients”.
 
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 has seen in its extensive ViV bench-top studies.
 
“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,” Anteris Technologies Chief Medical Officer Chris Meduri stated.
 
Anteris Technologies Ltd. designs, develops, and commercializes structural heart devices. Founded in Australia, with a significant presence in Minneapolis, Anteris is science-driven, with an experienced team of multidisciplinary professionals delivering transformative solutions to structural heart disease patients.

Reference 
¹ Garcia, S. (2022, 9 18). Fracturing Bioprosthetic THVs Shows Increased Mortality Risk, ‘Modest’ Hemodynamic Benefit, in ViV TAVR – Analysis. Retrieved from CRTonline.org: https://www.crtonline.org/news-detail/fracturing-bioprosthetic-thvsshows-increased-mort