FDA clears CorMatrix CanGaroo ECM envelope


CorMatrix Cardiovascular has announced that it has received US Food and Drug Administration (FDA) clearance to market the CorMatrix CanGaroo ECM envelope for use with cardiac implantable electronic devices, including pacemakers and implantable cardioverter defibrillators (ICD’s).

The CorMatrix CanGaroo ECM envelope is intended to securely hold a cardiac implantable electronic device in order to create a stable environment when implanted in the body. The CorMatrix CanGaroo ECM envelope is a pouch which holds an implantable device after implantation. It is constructed from a multi-laminate sheet of decellularised, non-crosslinked, lyophilised extracellular matrix derived from porcine small intestinal submucosa. The CorMatrix CanGaroo ECMenvelope will be provided in four sizes to fit an array of device types and sizes.

According to a company release, pre-clinical testing of the CorMatrix CanGaroo ECM envelope demonstrated that it was replaced with a vascularised tissue pouch at 90 day follow up that isolated the cardiac implantable electronic device within the normal tissue. In pre-clinical trials, the new vascularised tissue allowed for easy removal of the cardiac implantable electronic device.

The company announced that the first human implant of the CorMatrix CanGaroo ECM envelope was performed by Bruce Wilkoff, director of Cardiac Pacing and Tachyarrhythmia Devices at Cleveland Clinic.

“The CorMatrix CanGaroo was designed to address the needs described to us by physicians implanting cardiac implantable electronic devices in their daily practice. We are pleased that we can provide a device that our physician’s requested to address complications with device implantation,” says John Davis, executive vice president of Sales and Marketing, CorMatrix.

About extracellular matrix biomaterial

The decellularised matrix material serves as a bioscaffold to allow vascular ingrowth from adjacent tissues to deliver progenitor cells and nutrients to the matrix, which then differentiate into tissue-specific cells and structures. The matrix is gradually replaced as the patient’s own cells reinforces and rebuilds the diseased or damaged site. During repair, the matrix is naturally degraded and resorbed, leaving remodeled functional tissue where damaged or injured tissue would normally be expected. The safety of extracellular matrices has been well established in a number of different clinical applications and more than 500 published papers. Since 1999, an estimated two million patients worldwide have received an extracellular matrix implant.