CorMatrix Cardiovascular has received CE mark approval for its CorMatrix CanGaroo ECM envelope. It is intended for use with cardiac implantable electronic devices including pacemakers and implantable cardioverter defibrillators. The company received US Food and Drug Administration clearance to market the device in August 2014. CorMatrix ECM acts as a scaffold into which a patient’s cells migrate and integrate, stimulating natural wound healing mechanisms.
“With data trending toward increases in the number of implants in Europe, we are excited to make this device available to the Electrophysiology communities of Europe,” says Andrew Green, president and chief operating officer of CorMatrix.
The CanGaroo envelope is made from porcine derived extracellular matrix (ECM); rather than synthetic materials. When synthetic material is implanted, inflammatory “M1” macrophages are triggered which can result in fibrotic scar formation. Alternatively, the CorMatrix CanGaroo is made from ECM—a natural biologic that triggers a healing, regenerative “M2” response—intended to allow it to remodel into neo-vascularised tissue that is systemically connected. According to a company release, other benefits of the device include stabilisation, support and reinforcement of the pocket which may reduce the risk of device migration and erosion. It conforms to cardiac implantable electronic devices and may ease their removal during exchanges or revisions. In addition, the CanGaroo is soft and supple, with no sharp edges, which may enhance patient comfort.
The CorMatrix CanGaroo envelope is available in four sizes to fit an array of device types and sizes. The company will make the CanGaroo envelope available via its international distributors.