CorMatrix Reports FDA Clearance Of CorMatrix CanGaroo ECM Envelope

Posted on Oct 11 2014 - 5:05am by rizbaig

CorMatrix Cardiovascular announced today that it 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).

CorMatrix-CanGaroo-ECM-Envelope

“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”

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

Pre-clinical testing of the CorMatrix CanGaroo ECM Envelope demonstrated that 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,” commented John Davis, Executive Vice President of Sales and Marketing.

David Camp, Chief Executive Officer, added that “The addition of the CanGaroo ECM Envelope to our portfolio of FDA-cleared devices is a major milestone for CorMatrix and strengthens our leadership in the field of ECM® technologies.”