New class of aortic valve replacement delivers encouraging results

MedTech News: Australian structural heart company has delivered encouraging 12-month results from its transcatheter heart valve (THV) for patients with symptomatic severe aortic stenosis.

Anteris Technologies’ DurAVR first-in-human (FIH) study demonstrated a safety profile described as “outstanding” and has met all performance endpoints with remarkable hemodynamic function sustained for 12 months. Further, all safety endpoints were also met with no mortality (all causes), no disabling stroke, no life-threatening bleeding and no myocardial infarction at 12 months.

The DurAVR THV is a new class of aortic valve replacement devices that utilise the patented ADAPT anti-calcification process and innovative tissue-shaping technology in the world’s first single-piece transcatheter heart valve.

Anteris Technologies CEO, Wayne Paterson, said “This strong safety and hemodynamic data for DurAVR THV at 12 months reinforces the tireless work of the entire Anteris team, presenting powerful, real-world evidence of the benefit Anteris technology delivers to aortic stenosis patients.

“DurAVR THV demonstrates its single piece of shaped tissue and novel design result in biomimetic behaviours that mirror the function of a healthy human aortic valve. Furthermore, we see the restoration of severely stenotic aortic valves back to pre-disease states with normal function.

“This firmly establishes DurAVR THV in an entirely new class of replacement heart valves. These results represent a major clinical milestone and value catalyst in our journey to bring DurAVR THV to patients worldwide that need a better valve.”

DurAVR THV’s unique, first-in-class biomimetic design replicates the normal blood flow of a healthy human aortic valve.

Anteris CMO, Dr Chris Meduri, said “The DurAVR THV demonstrates how meaningful and differentiated innovation translates into real clinical benefits for patients suffering from aortic stenosis.

“The preservation of the impressive hemodynamics and safety out to 12 months in this first-in-human study is very encouraging. We are excited to expand this study to the United States in the near future with a recently FDA-approved early feasibility study (EFS),” Dr Meduri said.

Looking ahead, these encouraging preliminary first-in-human study results will be further validated in an FDA-approved early feasibility study (EFS) in early 2023.

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