Anteris Technologies (ASX:AVR) has reported data from its US Early Feasibility Study for DurAVR Transcatheter Heart Valve (THV), a new class of aortic valve replacement (AVR) and the world’s only biomimetic, single-piece transcatheter aortic valve.
The company said primary and key secondary endpoints of the US-EFS include safety and efficacy assessments, such as the success of implantation at the anatomically accurate position, and hemodynamic performance assessments, including effective orifice area (EOA), mean pressure gradient (MPG), paravalvular leak (PVL) and Doppler Velocity Index (DVI).
Patient outcomes such as stroke, myocardial infarction, life-threatening bleeds, and all-cause mortality are to be reported at 30 days, and 1 year post-implantation.
According to Dr Chris Meduri, Anteris’ chief medical officer, “While we still await 30-day hemodynamic and all-cause mortality results from this trial, the discharge timepoint is a key early indicator of how interventional cardiologists judge the success of a TAVR implantation. The unparalleled hemodynamic results (EOA, MPG, DVI) show that our single-piece, biomimetic product, DurAVR, can restore healthy normal pre-disease blood flow in acutely symptomatic patients. This data surpasses what is seen with commercial bioprosthetic valves available to date, and makes me, a practicing interventional cardiologist, very excited to bring this product to my patients in due course."
Anteris CEO Wayne Paterson added, "The US-EFS study was a critically important milestone in our journey to bring a new class of TAVRs into the market. Our US-EFS results not only corroborate what we have seen in the First-in-Human trial (N=20) but surpass all expectations. We are extremely proud of these landmark results and grateful to the physicians and patients who participated in the study."