Anteris Technologies Presents Data from 100 DurAVR(R) THV Patients at PCR London

Anteris Technologies (AVR) released 30-day clinical outcomes for the DurAVR THV in one hundred severe aortic stenosis patients with small aortic annuli – aortic annulus area 404 +/- 37mm2 -. The DurAVR THV demonstrated single digit mean gradients, large effective orifice areas, no moderate or severe paravalvular leaks and no valve related mortality, with 97% freedom from moderate or severe prosthesis-patient mismatch in a cohort of small annuli patients similar to the one reported in the SMART Trial. DurAVR THV delivered a favorable hemodynamic profile with a large EOA of 2.2 +/- 0.3 cm2 and a single digit mean pressure gradient of 8.2 +/- 3.1 mmHg. At 30-days, clinical safety outcomes were positive with no valve related mortality and no moderate or severe paravalvular leak. Prosthesis-patient mismatch was 3.0% compared with 11.2% to 35.3%1 for current commercial devices. A technical success rate of 100% was achieved in the last 50 consecutive patient implants. The global PARADIGM Trial 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.