Anteris Technologies Ltd (ASX:AVR, OTC:AMEUF) continues to receive "exceptional" patient outcomes for the first-in-human study of its novel DurAVR™ transcatheter heart valve (THV).
Preliminary results from a third patient cohort show 100% procedural success with no device-related complications in seven patients who received the DurAVR implant.
Anteris Technologies chief medical officer Chris Meduri was upbeat about the encouraging clinical results and excellent patient outcomes, saying they build on the body of evidence that supports the use of DurAVR THV in patients with aortic stenosis.
“Furthermore, the restoration of normal flow, which is a function of the biomimetic design, has not been observed with existing therapies and will have significant clinical benefits both in the short and longer term for patients," he added.
Good outcomes
The mean age of the participants is 74.86 years, with heart failure extents of 71% and 29% based on New York Heart Class II and III.
The preliminary results show:
- Transesophageal echocardiogram (TEE) taken 48 hours post-procedure showed favourable results – average Effective Orifice Area (EOA, cm2) increased from 0.76 to 2.11, a 178% increase from baseline – an indicator of improved long-term survival and exercise capacity; and
- Mean Pressure Gradients (MPG, mmHg) decreased by 84% from a baseline of 53.34 to 8.66 post-procedure (48 hours).
The patient’s EOA increased 250% from a baseline of 0.60 to 2.10 48-hours post-procedure, while MPG decreased from a baseline of 79.00 to 19.00 mmHg post-procedure, for a 76% improvement.
Further validation
“We have now treated 21 patients, all of whom have had outstanding results,” Anteris Technologies chief executive officer Wayne Paterson said.
“This recent cohort of patients further validates the exceptional clinical characteristics of DurAVR THV and the performance of our novel first-in-class biomimetic design.
“I would like to acknowledge the patients and physicians who are involved in this study and thank them for their participation.”