Anteris Technologies (ASX:AVR) said that one-year results for patients treated with its proprietary, balloon expandable, DurAVR Transcatheter Heart Valve system showed sustained "excellent" effective orifice area, low mean gradients, and zero prosthesis-patient mismatch small annuli patients, according to a Friday Australian bourse filing.
The DurAVR THV demonstrated a favorable hemodynamic profile sustained to one-year. No valve or cardiovascular-related mortality was reported.
Current commercial devices demonstrated prosthesis-patient mismatch rates of between 11.2% to 35.3%, a predictor of valve failure and disease progression.
The one-year data builds on the existing clinical evidence and will be included in the planned Investigational Device Exemption submission to the US Food and Drug Administration to seek approval to conduct a DurAVR THV randomized, global pivotal study.
A total of 65 patients completed the primary endpoint measure at 30 days.
Its shares slid 2% in early trading on Friday.
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