Admedus Limited (ASX: AHZ) has announced the initiation of a clinical study in aortic trileaflet heart valve reconstructions to repair aortic valvular disease such as aortic stenosis, using its cardiovascular bio-scaffold CardioCel.
CardioCel is on the market in North America, Europe and Asia and the company said this study aim to further support its use in heart valve repair and reconstructions.
The study follows the positive completion of a world first pre-clinical study using CardioCel, undertaken in conjunction with KU Leuven University and announced on 10 September 2015.
“Off the back of a very successful pre-clinical study, we have now commenced a clinical study to provide further data to use CardioCel for complete aortic valve reconstructions,” said CEO, Lee Rodne.
“This is an important study in aortic valve reconstruction, which has never been done before with a bio-prosthetic tissue like CardioCel. We believe the results will highlight the patient benefits of completely reconstructing the aortic valve with CardioCel compared to the current industry need of replacing it multiple times throughout a patient’s life.”
The study involves surgeons using CardioCel to reconstruct the three leaflets of the aortic valve as an alternative to replacing it with a bio-prosthetic valve.
According to the company, this provides an opportunity for autologous repair and the potential for patients to have a ‘native’ valve with better haemodynamic outcomes and overall improved health benefits compared to a replacement valve.
Aortic stenosis is the most common valvular heart disease in developed countries, with the incidence rate of around 25 per cent in people over the age of 65 and prevalence increasing with age.
The primary safety endpoint for the clinical study is to ensure same rates of in-hospital survival, while also looking for superior long-term benefits for patients, better haemodynamic outcomes, cell infiltration, regrowth of native tissue and long-term durability without calcification.
The study will enrol 80 adult patients at two European and two US sites, with initial cases already enrolled in the first week post ethics approval. Ethics approval has been received for the two European centres, KU Leuven University in Belgium and the German Heart Centre Munich, with US ethics approval expected in the coming months.
“While a majority of current aortic valve procedures follow the replacement strategy, we hope to show that reconstructing the valve with CardioCel is superior to replacing the valve and provides patients with long-term health benefits,” said Mr Rodne.
Patients in the clinical study will be reviewed 6, 12 and 24 months post-surgery to evaluate safety data and primary and secondary endpoints.