CorMatrix Receives FDA Clearance of CorMatrix CanGaroo ECM Envelope

CorMatrix Cardiovascular Inc. has received U.S. Food and Drug Administration (FDA) clearance to market the CorMatrix CanGaroo ECM Envelope for use with cardiac implantable electronic devices (CIED’s) including pacemakers and implantable cardioverter defibrillators (ICD’s).

The CorMatrix CanGaroo ECM Envelope is intended to securely hold a cardiac implantable electronic device (CIED) to create a stable environment when implanted in the body. The CanGaroo ECM Envelope is a “pouch” which holds a CIED after implantation, according to the company. It is constructed from a multi-laminate sheet of decellularized, non-crosslinked, lyophilized extracellular matrix derived from porcine small intestinal submucosa (SIS). The CanGaroo Envelope is available in four sizes to fit an array of device types and sizes.

Pre-clinical testing of the CanGaroo ECM Envelope showed it was replaced with a vascularized tissue pouch at 90 day follow up that isolated the CIED within the normal tissue. In pre-clinical trials, the new vascularized tissue allowed for easy removal of the CIED.

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

The CanGaroo’s decellularized 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 2 million patients worldwide have received an extracellular matrix implant.

CorMatrix Cardiovascular was founded in 2001 as a privately held medical device company to develop biomaterial devices that harness the body’s own innate ability to repair damaged cardiovascular tissues. Headquartered in Atlanta, Ga., the company currently is researching, developing and commercializing the CorMatrix ECM platform technology for various cardiovascular indications. It has FDA clearance and European approval for its ECM technology as an implant for pericardial repair and reconstruction, cardiac tissue repair, as well as clearance for carotid artery repair.