- Meditech specialist Anteris Technologies (ARV) reports “excellent” results from the first-in-human trial of its DurAVR replacement heart valve
- The company has surgically installed the valve in five patients of a 10-patient trial, with positive results recorded at the 30-day follow up point
- There were no adverse events in any patients, with some key measures of heart valve function improved compared to other replacement heart valves
- Anteris says importantly, exercise tolerance in patients was greatly improved compared to other observed studies of replacement valves
- Shares in Anteris Technologies are slightly lower this afternoon, down 0.59 per cent to trade at $16.90
Meditech specialist Anteris Technologies (ARV) has reported “excellent” results from the first-in-human trial of its DurAVR replacement heart valve.
The transcatheter aortic valve replacement (TAVR) product is designed to be a functional cure for severe aortic stenosis — a condition where the heart’s aortic valve narrows, reducing blood flow to the body and forcing the heart to work harder.
Anteris has surgically installed the DurAVR valve in the first five patients of a planned 10-patient study, with positive results recorded at the 30-day follow-up point.
All five subjects, of which the mean age is 73, have so far reported no adverse events from the procedure. What’s more, Anteris has recorded an 86 per cent improvement in mean gradient, which is the standard measure of stenosis severity, compared to pre-treatment levels.
Further to this, mean gradients were up to 50 per cent lower than other conventional TAVR devices, according to Anteris, when matched to annular size.
There were no heart rhythm disturbances from the procedure, and echocardiographic (ECG) and CT scans showed normal leaflet mobility and consistent laminar flow, which are key functions of a working heart valve.
Importantly, the patients showed a 20 per cent increase from baseline in a six-minute walk test — suggesting a 170-per-cent improvement in exercise tolerance compared to observed studies of other TAVR valves.
Anteris Chief Medical Officer Chris Meduri, who led the study, said the exercise performance indicated early improvements in the quality of life in patients who received the DurAVR valve.
“The excellent results observed so far are a function of the proprietary 3D single-piece leaflet design of DurAVR that mimics a native aortic valve,” Dr Meduri said.
“These numbers are even more remarkable considering this cohort had small annular anatomy.”
He said given the mean age of the subjects, the improvement in exercise performance was “incredibly important”. However, Dr Meduri said it should be kept in mind that today’s results represent only a small number of patients.
Still, Dr Vinnie Bapat, a cardiothoracic surgeon at the Minneapolis Heart Insitute who was part of the team of implanting physicians in the trial, said DurAVR continued to exceed “very high expectations”.
“The haemodynamic performance, as well as valve function, is remarkable,” Dr Bapat said.
“Additionally, the lack of any conduction change (arrhythmia) across five patients is a testament to the engineering team’s ingenuity and focus on improving all aspects of TAVR for patients.”
Shares in Anteris Technologies were slightly lower this afternoon, down 0.59 per cent to trade at $16.90 as of 1:46 pm AEDT. The company has a $187.5 million market cap.