Anteris Technologies reports clinical outcomes for DurAVR THV in patients

Anteris Technologies (AVR) Global announced one-year clinical outcomes for the DurAVR Transcatheter Heart Valve, or THV, in symptomatic severe aortic stenosis patients with small aortic annuli. The DurAVR THV System demonstrated single digit mean gradients and large effective orifice areas, or EOAs, no moderate or severe paravalvular leaks and no valve related mortality at one year, with low prosthesis-patient mismatch at 30 days. One-year results highlights include: DurAVR THV delivered a favorable hemodynamic profile sustained to one-year, with an EOA of 2.1 + 0.2 cm2 and a mean pressure gradient, or MPG, of 8.6 + 2.6 mmHg; At one-year, clinical safety outcomes were positive with no valve related mortality and no moderate or severe paravalvular leak, or PVL; At 30-days, prosthesis-patient mismatch was just 1.5%, compared with 11.2% to 35.3%1 for current commercial devices, highlighting a meaningful reduction in a key predictor of valve failure and disease progression. The pooled cohort included 65 patients with small aortic annuli implanted with the DurAVR THV from the ongoing EMBARK Study and US Early Feasibility Study. The encouraging clinical outcomes observed to date in over 100 patients implanted with the DurAVR THV will be further validated in the Company’s recently initiated global pivotal trial. The PARADIGM Trial is a prospective, randomized controlled trial which will evaluate the safety and effectiveness of the DurAVR THV compared to commercially available transcatheter aortic valve replacements in the treatment of severe aortic stenosis.