Brisbane, Australia and Minneapolis, USA:
Anteris Technologies Ltd, (Anteris or the Company) (ASX: AVR) reported today that DurAVR™ Transcatheter Heart Valve (THV), a new class of aortic valve replacement (AVR) and the world’s only biomimetic, single-piece transcatheter aortic valve, was used to successfully treat patients as part of the DurAVR™ THV Early Feasibility Study (EFS or the Study) in the United States.
The EFS is an essential step towards receiving FDA approval in the US and commercialisation of this innovative medical technology.
Dr Azeem Latib, Director of Interventional Cardiology, Director of Structural Heart Interventions at Montefiore Health System, New York, and Study National Principal Investigator (IC), performed the first group of US DurAVR™ THV procedures. This first group of severe aortic stenosis patients treated with DurAVR™ THV had intraoperatively, post-implant EOAs of 2.2cm2, and average mean gradients of 4mmHg.
onwards and upwards
Ann: Montefiore enrolls Patients in US Early Feasibility Study, page-3
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