Allied Healthcare Group have announced that CardioCel® has received CE mark approval, allowing the company to launch and market the product in Europe. The CE mark for CardioCel® allows for the repair and reconstruction of heart defects including treating congenital heart disease and repairing heart valves in both children and adults.
In addition to commercial and scientific validation, the approval of CardioCel® technology in Europe offers a platform to launch additional cardiovascular products, as well as regenerative tissue products for the repair and reconstruction of other defects and diseases.
"CardioCel®'s approval in Europe provides the surgeons with an important addition to their treatment in the repair of cardiac defects, and offers children and adults suffering from cardiac defects and disease a promising new technology that displays strong levels of regeneration and long term benefits," stated Mr Rodne.
Allied Healthcare Group is expecting sales of CardioCel® in Europe to begin in the 4th quarter this calendar year.
This first approval is a platform from which the company can build a portfolio of regenerative tissue products for treatment of cardiac diseases and defects as well as other indications such as vascular reconstructions, hernia repair and pelvic floor reconstructions.
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.