According to preclinical data presented at EACTS (2–7 October, Amsterdam, the Netherlands), CardioCel can be successfully used to perform trileaflet repair in a sheep model with no or minimal calcification detected. Admedus, the company behind CardioCel, state that the results support the use of CardioCel in the complete reconstruction of aortic heart valves and that the device could be used to address the disadvantages found with existing bioprosthetic valves.
The study data were presented at 2015 European Association for Cardiothoracic Surgery (EACTS) meeting (3–7 October, Amsterdam, the Netherlands) by Bart Meuris (lead researcher at KU Leuven University, Belgium). According to a press release, the results of the study 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.
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 bioscaffold. The six month time-frame in sheep is representative of over 10 years of data in adult patients. The press release reports that 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. Meuris comments: “The results from the study are very positive and some of the best results we have seen in this model.”
Admedus recently announced a follow on aortic trileaflet 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.