Anteris Technologies (ASX:AVR) said clinical outcomes for the DurAVR transcatheter heart valve in symptomatic severe aortic stenosis patients with small aortic annuli showed single-digit mean gradients and large effective orifice areas, no moderate or severe paravalvular leaks, as well as no valve-related mortality at one year, according to a Wednesday Australian bourse filing.
The pooled group included 65 patients with small aortic annuli implanted with the DurAVR valve from the ongoing EMBARK study and the US early feasibility study. It reported an effective orifice area of 2.1 square centimeters, with a variation of 0.2 square centimeters, and a mean pressure gradient of 8.6 millimeters of mercury, with a variation of 2.6 millimeters of mercury.
It also showed low prosthesis-patient mismatch at 30 days, at just 1.5%.