Structural heart company Anteris Technologies Ltd (ASX:AVR, OTC:AMEUF) has presented the latest data from its DurAVR™ THV (transcatheter heart valve) first-in-human study at the Transcatheter Valve Therapy (TVT) Conference.
Excellent haemodynamics
The clinical results demonstrate that the DurAVR™ THV maintains excellent haemodynamic performance at both one year and 30-day time points.
The study has enrolled a total of twenty patients, with an average age of 74.25 years. The majority of the patients in the study – 80% - are female.
The patients have a mean annulus diameter of 22.7 mm. The New York Heart Class II and III classifications indicate that 80% of the patients have mild-to-moderate heart failure, while 20% have severe heart failure.
The implantation of the DurAVR™ THV was successful in 100% of the cases, with no complications related to the device.
The first 12 patients have completed their one-year follow-up, and the results demonstrate sustained haemodynamic performance.
The mean effective orifice area (EOA), which measures the effective opening of the valve, was reported to be 1.98 square centimetres. The mean pressure gradients (MPG), which measures the pressure difference across the valve, were reported to be 9.22 mmHg.
Unique clinical characteristics
All study patients have reached their 30-day follow-up, and the results align with previously reported data. The EOAs increased by 192% from 0.69 square centimetres at baseline to 2.02 square centimetres at 30 days. Additionally, the MPG decreased by 84% from 53.34 mmHg to 8.50 mmHg.
Anteris Technologies CEO Wayne Paterson said: “These results further validate the unique clinical characteristics of DurAVR™ THV and the performance of the novel first-in-class biomimetic design.
“We continue to be encouraged by the results from the DurAVR™ THV First-In-Human Study and are pleased to see the sustained haemodynamic performance at one year. This supports the ongoing thesis that DurAVR™ THV, a new class of valve, will be an important treatment option for patients in the future.”
Anteris Technologies chief medical officer Chris Meduri MD, added: “This is another step forward as we continue building upon the body of evidence that supports the use of DurAVR™ THV in patients with aortic stenosis.
“We remain pleased with the clinical results and excellent patient outcomes we have seen to date.”
About Anteris Technologies
Anteris Technologies focuses on developing next-generation technologies for structural heart interventions.
Its DurAVR™ 3D single-piece aortic heart valve replacement, built on the patented ADAPT® tissue technology, aims to provide superior performance and durability for younger and more active patients with aortic stenosis.
The company's goal is to deliver life-changing outcomes for patients and address the challenges faced by doctors in treating aortic stenosis worldwide.