Data collected from the first four sheep suggests 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.
The study has demonstrated that these stentless valves can be implanted with reasonable ease, without any major adverse event.
Admedus chief medical officer Dr Kiran Bhirangi said: “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.
“The findings are very encouraging for several reasons. The sheep model is well accepted and a good predictor of the effectiveness of the technology.”
Proven resistance to calcification
Admedus CEO Wayne Paterson said: “Calcification is a major issue for surgeons and patients today when treating valvular disease.
“Our ADAPT® tissue is the only product of its kind that has data demonstrating ten years without calcification or degradation. Combining this unique benefit with the first and only single piece 3D valve could be a major disruption in the treatment strategies for patients in the future.
Potential market leader in US$12 billion market
“ADAPT® TAVR would be a breakthrough for patients needing valve replacement.
“The TAVR market is expected to be $US12 billion by 2025. If the earlier results translate to true clinical superiority, ADAPT® TAVR could be well placed to be the market leader.
Preliminary data but well-studied
“It’s important to acknowledge the preliminary nature of this data. However, the combination of a novel single-piece 3D aortic valve and the ADAPT® technology which has been studied for ten years and is already used in over 16,000 patients is showing demonstrable clinical benefits.”