Anteris Technologies Ltd (ASX:AVR, OTC:AMEUF) says new data from its first-in-human DurAVR™ transcatheter heart valve trial represent the best results to date at the 30-day mark, giving it a shot in the arm as it develops solutions for younger and more active aortic stenosis patients.
The structural heart company presented data from its latest patient cohort at the TVT conference in Arizona last week, showcasing its findings at a summit designed to spotlight cutting-edge research and techniques for structural heart interventions.
The results show the DurAVR valve maintained excellent haemodynamic performance at 30 days (as previously reported with this patient cohort at 48 hours post-procedure), while preliminary results indicate 100% implant success (with no device-related complications).
Anteris Technologies CEO Wayne Paterson said results from the latest seven patients signalled that DurAVR continued to perform well in small annulus sizes.
“We saw greater haemodynamic improvement in these difficult-to-treat patients and this encouraging data continues to support the thesis that DurAVR, a new class of biomimetic valve, will be an important treatment option for patients in the future.”
Study snapshot
Anteris’ latest results come from its first-in-human transcatheter heart valve trial — findings from which are slated for validation in an FDA-approved early feasibility study.
The cohort’s average age group was around 75 years old, while the vast majority of participants (86%) were female.
Technically speaking, Anteris saw the average effective orifice area increase by 168% from baseline — an indicator of a patient’s increased long-term survival and exercise capacity. The findings also indicate that the mean pressure gradient reduced by 87%.
Anteris used the New York Heart Association’s (NYHA) Functional Classification to measure the extent of heart failure across the seven-patient cohort, essentially placing participants in one of four categories based on limitations to physical activity.
Around 71% of the cohort was categorised as class two participants, meaning they experienced light limitation but remained comfortable at rest, while the balance of patients (29%) was classified as class three, meaning that less than ordinary activity caused fatigue, palpitation, shortness of breath or chest pain.
Anteris’ DurAVR heart valve is designed to mitigate these issues, particularly in younger and more active aortic stenosis patients.
The company has crafted its 3D single-piece aortic valve to deliver superior performance and durability through innovations designed to last the remainder of a patient’s lifetime.