Cingular has excellent anti-calcification technology of biological valve materials and special biological material treatment process to ensure the long-term anti-calcification performance of the valve. Schoen FJ, et al 1 in their study found that the degree of calcification reached 200 µ g / mg after 8 weeks (56 days) of subcutaneous implantation in rats using glutaraldehyde pretreated bovine pericardial material.
Crystal M. Cunanan et al., in their patent study 2, found that the degree of calcification reached 124.04 µ g / mg after subcutaneous implantation in rats for 30 days without anti calcification treatment.
Cingular experimental results on the calcification of valve tissue in subcutaneous implantation in 8-week rats were excellent, and the amount of valve calcification was much smaller than that of anti calcification or non anti calcification treated valve material in these experimental studies. 8,9 moreover, no calcification related adverse events were observed in subsequent animal experiments or clinical trials.
References：1.Schoen FJ, Tsao JW, Levy RJ. Calcification of bovine pericardium used in cardiac valve bioprostheses. Implications for the mechanisms of bioprosthetic tissue mineralization. Am J Pathol. 1986 Apr;123(1):134-45.
2.Crystal M. Cunanan, Lillian Quintero, Michael N. Helmus, Method for fixation of biological tissues having mitigated propensity for post-implantation calcification and thrombosis and bioprosthetic devices prepared thereby. Patent No.: US 6214054B1, Apr.10, 2001