Next month Admedus will kick off the new year with the start of...

Next month Admedus will kick off the new year with the start of its in Human Feasibility Study With ADAPT 3D. The trial will involve 15 patients and will be conducted in Belgium by Prof Bart Meuris. Prof Meuris conducted the sheep study and you can see a comment from him below regarding some of those results. A link to the details of the study is further below.

”This study has demonstrated that these stentless valves can be implanted with reasonable ease, without any major adverse event,” said Prof Bart Meuris, Cardiac Surgeon at KU Leuven, where the study is being conducted.“The echocardiograms revealed superior functional valves with optimal hemodynamic profiles. We support the progression to a first-in-human clinical trial, and believe clinical implantation of this device is certainly possible in the short term and can be beneficial to many patients.”

This was from Dr Kiran Bhirangi, Admedus’ Chief Medical Officer.

“The findings are very encouraging for several reasons. The sheep model is well accepted and a good predictor of the effectiveness of the technology. The EOA, which is an important factor in enabling the flow of fluid, or blood, is significant, given that valves in the market today have an EOA of 1.6 to 2. While the Admedus single-piece valve has demonstrated an EOA up to 2.5, the researchers will continue to monitor, and report on the five-month explant data, but based on the current findings we are confident to take next steps towards human clinical trials.”

https://clinicaltrials.gov/ct2/show/NCT04178213