Allied Healthcare Group out of Brisbane, Australia won the CE Mark for its CardioCel bioabsorbable patch to be used for repair of myocardial tissue. It’s indicated for use with children and adults, and can be utilized during congenital disease repair or for work on on a variety of other conditions like major vessel outflow tract repairs. The patch is made out of bovine pericardium, is completely biocompatible, and promotes the body’s own cells to gather on its surface and become one with the tissue around it.
Allied Healthcare Group plans to offer the CardioCel in Europe at the end of this year.
From the announcement:
CardioCel® offers key benefits for patients and surgeons including showing strong levels of regeneration of self-tissue without needing external stem cells or growth factors and no cytotoxicity at the site of repair, thereby reducing the issue of calcification which can often lead patients to have repeat surgeries. CardioCel® is also ready to use, off the shelf, saving time during surgery.Allied Healthcare Group is also pursuing approval for CardioCel® in the USA and anticipates US approval in 2014.
Press release: ALLIED GRANTED CE MARK FOR LEAD REGENERATIVE PRODUCT CARDIOCEL®
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