Anteris Technologies Ltd (ASX:AVR, OTC:AMEUF) is making strides towards obtaining United States Food and Drug Administration (FDA) approval for its flagship DurAVR™ transcatheter heart valve (THV) after positively treating patients as part of an early feasibility study (EFS) on the device.
The EFS is an essential step towards receiving FDA approval and commercialisation of the structural heart company’s DurAVR™ THV.
This study aims to evaluate the safety and feasibility of the device in treating patients with symptomatic severe native aortic stenosis.
Breakthrough moment
New York-based Montefiore Health System director of Interventional Cardiology and Structural Heart Interventions Dr Azeem Latib, who is also the national principal investigator of the study, performed the initial DurAVR™ THV procedures in the US.
The first group of severe aortic stenosis patients treated with DurAVR™ THV demonstrated promising results, with intraoperative effective orifice area (EOAs) of 2.2cm and average mean gradients of 4mmHg post-implant.
“Having previously travelled to Europe with Anteris to implant patients with DurAVR™ THV, I am delighted to note that the post-procedure patient outcomes seen in US patients at my centre corroborate with data reported from previous cohorts,” Latib said.
“The ability to use this device with such excellent hemodynamic results, as well as ease of use, is incredible progress in the treatment of patients with severe aortic stenosis.
“We look forward to many more cases in the near future.”
Key study
The EFS involves more than 15 subjects across seven heart valve centres of excellence in the US, with chair of Cardiovascular Research at the Houston Methodist DeBakey Hospital, Dr Mike Reardon, leading the study.
This FDA-designated category B study is set to assess safety and device feasibility as its primary endpoint within 30 days post-implantation.
The data gathered from the study is expected to pave the way for a pivotal registrational trial, further advancing the DurAVR™ heart valve.
Alternative therapy
“The successful treatment of these patients in the United States is yet another important milestone on our path to commercialisation of the DurAVR™ TAVR system,” Anteris Technologies chief executive officer Wayne Paterson said.
“The patients enrolled at Montefiore Hospital in New York this week add to our body of evidence that supports the use case of DurAVR™ THV and its clinical superiority and validates the reproducibility of our data and the stellar performance to date.
“Today’s patients had excellent outcomes with intraoperative mean gradients of 4mmHg.
“This further supports the case that DurAVR™ is both clinically viable and will be an important product for the treatment of aortic stenosis in the future, giving patients and physicians alternatives to current therapies.”