CorMatrix® Cardiovascular Incorporated announced that it has received CE mark approval for its CorMatrix® CanGaroo® ECM® Envelope. It is intended for use with cardiac implantable electronic devices (CIED's) including pacemakers and implantable cardioverter defibrillators (ICD's). The CanGaroo® differs from other device pockets on the market because it's made from porcine derived extracellular matrix (ECM); not synthetic materials.
CorMatrix Cardiovascular, Inc., a leading developer of biomaterials and medical devices, announced the treatment of the first patients using its CorMatrix® Tyke®, a product specifically designed and cleared for cardiac tissue repairs in neonates and infants. The product received FDA 510(k) clearance in February 2016. Tyke® is made of 2 layers of CorMatrix® ECM® as compared to the 4 layers of the current Cardiac Tissue Repair, therefore providing a thinner product for smaller repairs.
CorMatrix announces treatment of the first patient to receive their tissue engineered regenerative CorMatrix® ECM® Tricuspid Valve. The operation was performed by Marc Gerdisch, MD, FACS, FACC, Chief of Cardiovascular and Thoracic Surgery at Franciscan St. Francis Health in Indianapolis. The Company received approval for the CorMatrix® ECM® Tricuspid Heart Valve as an early feasibility study approved through the FDA Investigational Device Exemption (IDE).