CorMatrix® CanGaroo® ECM® Envelope Receives CE Mark Approval
ROSWELL, Ga.CorMatrix® Cardiovascular Incorporated, a
company specializing in its extracellular matrix (ECM®) technology announced
today 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 company received U.S. FDA clearance to market the device in August
of 2014. CorMatrix® ECM® acts as a scaffold into which a patient’s cells migrate
and integrate, stimulating natural wound healing mechanisms.
In recent world surveys of cardiac pacing most European countries showed an increase in new CIED implants per million population compared with previous years. “With data trending toward increases in the number of implants in Europe, we’re excited to make this device available to the Electrophysiology communities of Europe,” said Andrew Green, President and Chief Operating Officer of CorMatrix.
The CanGaroo® differs from other device pockets on the market because it’s made from porcine derived extracellular matrix (ECM); not synthetic materials. When synthetic material is implanted, inflammatory “M1” macrophages are triggered5, 6 which can result in fibrotic scar formation. Alternatively, the CorMatrix CanGaroo is made from ECM—a natural biologic that triggers a healing, regenerative “M2” response 5, 6 allowing it to remodel into neo-vascularized tissue that is systemically connected. Other benefits of the device include stabilization, support and reinforcement of the pocket which may reduce the risk of device migration and erosion. It conforms to CIEDs and may ease their removal during exchanges or revisions. In addition, the CanGaroo® is soft and supple, with no sharp edges which may enhance patient comfort.
The CorMatrix® CanGaroo® envelope is available in four sizes to fit an array of device types and sizes. The company will make the CanGaroo available via its international distributors.
Source: CorMatrix Cardiovascular, Inc.
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