Medtech innovator reports promising milestone for transcatheter heart valve technology

MedTech & Diagnostics News: The introduction of transcatheter aortic valve implantation (TAVI) has revolutionised the management of aortic valve disease in Australia, with Medtronic, Edwards Lifesciences and Abbott as key innovators in this market.

Australian medtech company, Anteris Technologies, has announced a US utility patent for its novel DurAVR transcatheter heart valve (THV) replacement technology which expires in September 2042.

The ASX-listed company said DurAVR is the first biomimetic valve of its kind, designed to mimic the performance of a healthy human heart valve. Anteris also believes the strong clinical results to date are due to the distinctive features of the DurAVR design, such as the single-piece valve construction.

“The patent signifies the extraordinary work by our team of engineers around the world responsible for the design of DurAVR THV,” said CEO Wayne Paterson.

He added “The granting of this patent enhances the broad IP protection of DurAVR, strengthening our competitive position in the TAVR field.”

The company’s Advisory Board was strengthened recently with the addition of Dr Karl Poon, one of Australia’s most prolific implanters of TAVR devices who participated in the implantation of the second cohort of the first-in-human study.

“Having had the privilege of implanting DurAVR as part of the first-in-human study, we witnessed superior haemodynamic performance immediately. We need to restore normal cardiac and heart valve function after valve replacement and allow patients to enjoy an active lifestyle. DurAVR’s clinical impact is extremely promising,” said Dr Poon, Structural and Coronary Interventional Cardiologist, St Andrews War Memorial Hospital, Brisbane.

In January 2023 the company released the 12 month results for the first cohort of five patients from the DurAVR THV Aortic Stenosis first-in-human study. All performance endpoints were met with remarkable haemodynamic function sustained at 12 months. The system demonstrated an outstanding safety profile: no mortality (all causes), no disabling stroke, no life-threatening bleeding, and no myocardial infarction. These encouraging preliminary first-in-human study results will be further validated in an FDA-approved early feasibility study in 2023.

Anteris claims DurAVR 3D single-piece aortic heart valve replacement meets the needs of today’s younger and more active aortic stenosis patients. The company added that the DurAVR 3D single-piece aortic heart valve’s distinctive design and the well-established advantages of its patented ADAPT tissue technology could offer aortic stenosis patients all over the world a treatment that could change their lives.

Aortic valve stenosis is the most common valvular lesion in Australia, with a rising prevalence in line with the ageing population. Since July 1, 2022, transcatheter aortic valve implantation (TAVI) has been funded on the Medical Benefits Scheme (MBS) for patients with symptomatic severe aortic stenosis at low surgical risk, 12 months after it was positively recommended by the Medical Services Advisory Committee (MSAC).

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