Anteris Technologies Ltd (ASX:AVR) is well on the way to achieving its operational goal for 2020 of completing the study of its proprietary DurAVR™ Transcatheter Heart Valve.
Initial study results have been released over the last few months and today the company will present data from the first-in-human trial to the PCR London Valves 2020 virtual conference.
Notably, the DurAVR™ 3D single-piece aortic valve has been selected as a 'Best Innovation' at the conference.
Superior performance and durability
Anteris chief executive officer Wayne Paterson said: “To be featured as a Best Innovation at PCR London Valves is a highly coveted honour, with all entries reviewed by a panel of independent experts.
“To be selected speaks to the quality of the clinical and pre-clinical evidence demonstrating the superior performance and durability of DurAVR™ and the genuine interest in its potential to significantly improve outcomes for patients.”
Results presentation
Professor Bart Meuris MD, PhD, chief of cardiovascular surgery at the University Hospitals, Leuven, Belgium and principal investigator of Anteris Technologies’ first-in-human study will present on the company’s behalf.
Dr Meuris will provide an overview of the DurAVR™ heart valve and results generated to date in the first-in-human study.
The Anteris DurAVR™ aortic replacement valve addresses the acute need in terms of superior hemodynamic profile as well as chronic needs in its ability to sustain that profile longer over the lifetime of the patient.
Trial observations
Early results from the first-in-human study of the DurAVR™ aortic valve have found that patient outcomes exceeded the results of what is normally expected following a Surgical Aortic Valve Replacement (SAVR).
Key observations from the trial include:
- DurAVR™ can restore normal predisease hemodynamics and has the potential to be a functional cure for the treatment of severe aortic stenosis;
- Patient recovery was swift, and no stay in an intensive care unit was needed; and
- This technology, with both surgical and transcatheter options, offers a potentially more durable solution for enhancing acute and longterm outcomes for patients with aortic valve disease.
The data suggests that DurAVR™ when compared to other valves demonstrates the normal hemodynamic function of a healthy pre-diseased valve and if these results continue, DurAVR™ will be the first TAVR valve to deliver a truly functional cure for severe aortic stenosis patients.
Anti-calcification attributes
The company’s proprietary ADAPT® tissue platform, the technology behind DurAVR™, was part of an anti-calcification comparison study and demonstrated that ADAPT® treated tissue has superior anti-calcification attributes compared with tissues used in competitor valves.
Results at the half-way point of four months showed ADAPT® had approximately 40% less calcium concentration compared with the Medtronic AOA™ arm – tissue used in commercially available SAVR (surgical aortic valve replacement) and TAVR (transcatheter aortic valve replacement) valves.
The interim results correlated with existing clinical data and those of the prior head-to-head study with a similar protocol which produced significant differentials between ADAPT® tissue and Edwards Life Sciences’ Thermafix tissue at the eight to 12-month mark.
The final results of the eight-month study will be used in the US Food and Drug Administration submissions to demonstrate DurAVR™ superiority compared with currently available valves subject to the final results being consistent with these positive interim results.