Anteris Technologies Ltd (ASX:AVR, OTC:AMEUF)’s first-in-human DurAVR™ THV study met or exceeded its interim study objectives, with patients reporting 'impressive' haemodynamic improvement.”
Patients' functional status improved, as did their exercise performance, indicating early improvements in quality-of-life after receiving DurAVR™.
The company plans to continue the study with the next cohort, as well as recruit patients for its US Food and Drug Administration (FDA) investigational device exemption (IDE) study.
More results during 2022
Anteris CEO Wayne Paterson said: “The excellent results observed so far are a function of the proprietary 3D single-piece leaflet design of DurAVR™ that mimics a native aortic valve.
“These numbers are even more remarkable considering this cohort had small annular anatomy.
“Furthermore, patients’ functional status improved as did their exercise performance indicating early improvements in quality-of-life due to receiving DurAVR™.
“As the mean age of patients in this study is 73 this improvement in exercise performance is incredibly important and supports the use of DurAVR™ in this more active patient group who require a valve that lasts longer and works better than current solutions.
“The current data represents a small number of patients and should be viewed as such.
“However, we look forward to continuing the study with the next cohort as well as recruiting patients for our FDA IDE study and reporting more results during 2022.”
“Exceed very high expectations”
Anteris' chief medical officer, TAVR interventionalist and study leader Dr Chris Meduri added: “DurAVRTM continues to exceed very high expectations in a complex group of bicuspid and tricuspid patients.
“The haemodynamic performance, as well as valve function, is remarkable.
“Additionally, the lack of any conduction change (arrhythmia) across five patients is a testament to the engineering team’s ingenuity and focus on improving all aspects of TAVR for patients.
“All signs continue to point to success in our mission of making available a TAVR that works better from the get-go and lasts longer.”
Watch: Anteris Technologies' 30-day data from in-human heart valve trial yields promising results
Results
At the 30-day follow up point, the first five patients of the planned 10-patient study showed:
➢ All five subjects continued to do well with no reported adverse events (no death, stroke, myocardial infarction, reintervention);
➢ An average 86% improvement in mean gradient (standard measure of stenosis severity) from pre-treatment levels;
➢ Mean gradients were up to 50% lower than other transcatheter aortic valve replacement (TAVR) devices when matched to annular size. All patients are in the normal or near-normal range when compared to the general population with normal valve function.
➢ Average Effective Orifice Area (EOA) was up to 45% larger than those reported with other TAVR devices in matched annular sizes;
➢ No conduction (heart rhythm) disturbances due to the procedure;
➢ No clinically significant paravalvular regurgitation despite very complex and heavily calcified anatomy;
➢ Echocardiographic and CT analysis reported normal leaflet mobility, no leaflet calcification or thrombus generation;
➢ Echocardiographic and CT imaging data showed consistent laminar flow throughout the valve and long coaptation length in all five patients. Ostensibly, these features indicate lower leaflet strain leading to long term durability;
➢ The system allowed for excellent commissural alignment; a significant patient benefit if future coronary intervention were required; and
➢ A 20% increase from baseline in the 6-minute walk test (a measure of patient exercise tolerance). This is a 170% greater improvement than observed in studies of other TAVR valves and indicates a marked improvement in patients’ functional status and exercise tolerance. The improvement in exercise capacity may be associated with the increased EOA (larger valve opening area due to its unique design) allowing optimal haemodynamics (blood flow) at rest and during exercise. Exercise performance is a critical marker of cardiac health.
DurAVR™
Anteris’ DurAVR™ 3D single-piece aortic heart valve replacement addresses the needs of tomorrow’s younger and more active aortic stenosis patients by delivering superior performance and durability through innovations designed to last the remainder of a patient’s lifetime.
The proven benefits of its patented ADAPT® tissue technology, paired with the unique design of its DurAVR™ 3D single-piece aortic heart valve, have the potential to deliver a game-changing treatment to aortic stenosis patients worldwide and provide a much-needed solution to the challenges facing doctors today.