ROSWELL, Ga. & CLEVELAND -- (BUSINESS WIRE) -- 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).
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 (ECM®) derived from porcine small intestinal submucosa. The CorMatrix® CanGaroo™ ECM® Envelope will be provided in four sizes to fit an array of device types and sizes.
The first human implant of the CorMatrix® CanGaroo™ ECM® Envelope was performed by Dr. Bruce Wilkoff, Director of Cardiac Pacing and Tachyarrhythmia Devices at Cleveland Clinic.
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.
Background of Extracellular Matrix (ECM) Biomaterial
The 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 ECM® material 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.
Safe Harbor Statement
This press release includes statements that look forward in time or that express management's beliefs, expectations or hopes. Such statements are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, the anticipated approval of pending and future patent applications related to CorMatrix® ECM® Technology, the Company's future patent application filings and the protection of the Company's intellectual property provided by any patents that issue. These statements are based on current information and belief, and are not guarantees of future performance. Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include that pending and future patent applications related to CorMatrix® ECM® Technology may not result in issued patent, that the issuance of any patents may be delayed, that the allowed claims, if any, may not be in line with the Company's expectations, that the Company may not be successful in enforcing its patents, and other risk factors for privately-held companies. By making these forward-looking statements, the Company does not undertake to update them in any manner except as may be required.