FDA Clears CorMatrix® CanGaroo™ ECM® Envelope for Cardiac Implantables

CorMatrix® Cardiovascular says it has received U.S. 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).

Background

Use of Extracellular Matrix (ECM) Biomaterial is becoming commonplace in implantable devices. Effectively a decellularized material, it 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.

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.

While the basic principle is similar to that of the TYRX envelope, acquired by Medtronic earlier this year, the fundamental difference lies in the goal of the TYRX device being to reduce infection by incorporation of an antibiotic in its AIGISRx® R Envelope.

Company comments

“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.”

Source: CorMatrix® Cardiovascular, Inc., Business Wire

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