Admedus Limited has announced positive data from its pre-clinical aortic tri- leaflet reconstruction study using CardioCel®. The study data was presented on the 5th of October by Professor Bart Meuris at the European Association for Cardiothoracic Surgery (EACTS) meeting in Amsterdam.
The results from the study show successful valve reconstructions and support the use of CardioCel in the complete reconstruction of aortic heart valves and aims to address the disadvantages found with existing bio-prosthetic valves.
"This study and data are extremely important as they clearly show the benefits of reconstructing heart valves with CardioCel compared to using a bio-prosthetic valve. It further illustrates the benefits of the ADAPT tissue engineering process and its ability to produce superior regenerative tissue products," said Admedus CEO Mr Lee Rodne.
The study undertaken at KU Leuven University in Belgium examined nine leaflets replaced in three sheep. Results showed no or minimal calcification detected, with only minimal calcification seen around the sutures and a commissure. In addition, the valves were competent, demonstrating positive haemodynamics, with no leakage and excellent coaptation of the leaflets post reconstruction.
"The results from the study are very positive and some of the best results we have seen in this model," said Professor Bart Meuris, lead researcher at KU Leuven University.
After six months, new collagen had formed on both sides of the leaflet as a clear sign of post- surgery remodelling around CardioCel, with host fibroblasts detected within the CardioCel bio- scaffold. The six month time-frame in sheep is representative of over 10 years of data in adult patients.
The study results demonstrate that CardioCel, which is now used in 110 heart centres, shows clear advantages over replacement of the aortic valve or reconstruction with other tissues.
Admedus recently announced a follow on aortic tri-leaflet heart valve reconstruction clinical study using CardioCel to repair aortic valvular disease in patients. The clinical study will take place in Europe and the US to further support the use of CardioCel in heart valve repairs and reconstructions. KU Leuven Hospital has already received ethics approval to participate in the clinical trial.