Medical technology company Admedus Ltd is pleased to advise that interim data from the animal study of its single-piece 3D aortic valve suggest that the device can be implanted safely and has the potential to deliver meaningful clinical benefits.
Medical technology company Admedus Ltd (ASX: AHZ) is pleased to advise that interim data from the animal study of its single-piece 3D aortic valve suggest that the device can be implanted safely and has the potential to deliver meaningful clinical benefits.
Following the positive findings in this feasibility study, Admedus now confirms it could initiate a first-in-human clinical trial earlier than expected.
To date, five sheep have been implanted and will be monitored for five months. Echocardiographic data from the first four animals, at approximately four weeks after implantation, showed Effective Orifice Areas (EOA) with a range of 2- 2.5cm2. No regurgitation was observed, and there was a low-pressure gradient across the valves (4-6 mmHg).
“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.”
“The purpose of this feasibility study is to assess whether there is merit to progress to a larger animal study, and human clinical trials — and the results we have so far strongly support this,” said 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
