CE mark for device that repairs heart defects


Allied Healthcare Group has announced the launch of its recently CE-marked CardioCel device, which can be used for repair and reconstruction of heart defects (including congenital heart disease and malfunctioning heart valves) in both children and adults.  

The chief executive officer of Allied Healthcare Group, Lee Rodne, says: “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.”

The company has said that it will now look to take advantage of the CE mark approval to start selling the product throughout Europe. A press release reports that in addition to commercial and scientific validation, the approval of CardioCel technology in Europe offers a platform to launch additional cardiovascular products.