CorMatrix CanGaroo ECM Envelope Receives CE Mark Approval

CorMatrix Cardiovascular Inc., a company specializing in its extracellular matrix (ECM) technology, has received CE mark approval for its CorMatrix CanGaroo ECM Envelope. The product is intended for use with cardiac implantable electronic devices (CIED’s) including pacemakers and implantable cardioverter defibrillators (ICD’s). The device was cleared by the U.S. Food and Drug Administration in August 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, ^1,2,3,4 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 triggered^{5, 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 through its international distributors.
 
CorMatrix Cardiovascular is a privately held company that develops biomaterial devices that harness the body’s own innate ability to repair damaged cardiac and vascular tissues. CorMatrix ECM technology allows surgeons to restore the native anatomy of cardiac and vascular tissue in need of repair, serving as a superior alternative to synthetic or cross-linked materials. Headquartered in Roswell, Ga., the company is currently researching, developing and commercializing a platform technology known as CorMatrix ECM for a variety of cardiovascular and other indications, and has U.S. clearance and European registration (with a CE Mark) for its ECM technology. Since its launch in 2006, CorMatrix ECM technology has been used at more than 975 hospitals across the United States and has been implanted in more than 145,000 cardiac procedures.

References:
1. Mond HG, Irwin M, Morillo C, et al. The world survey of cardiac pacing and cardioverter defibrillators: calendar year 2001. Pacing Clin Electrophysiol 2004; 27(7):955-64
2. Mond HG, Irwin M, Ector H, et al. The world survey of cardiac pacing and cardioverter defibrillators: calendar year 2005 an International Cardiac Pacing and Electrophysiology Society (ICPES) project. Pacing Clin Electrophysiol 2008; 31(9):1202-12.
3. Mond HG, Proclemer A. The 11th world survey of cardiac pacing and implantable cardioverter-defibrillators: calendar year 2009–a World Society of Arrhythmia’s project. Pacing Clin Electrophysiol 2011; 34(8):1013-27.
4. Ector H and Vardas P. Current use of pacemakers, implantable cardioverter defibrillators, and resynchronization devices: data from the registry of the European Heart Rhythm Association. Eur Heart J (2007): 9(suppl I), 144-149.
5. ECM-Based Materials in Cardiovascular Applications: Inherent Healing Potential and Augmentation of Native Regenerative Processes Anna V. Piterina, Aidan J. Cloonan, Claire L. Meaney, Laura M. Davis, Anthony Callanan, Michael T. Walsh and Tim M. McGloughlin; Int. J. Mol. Sci. 2009, 10(10), 4375-4417; doi: 10.3390/ijms10104375
6. Exploring the full spectrum of macrophage activation David M. Mosser and Justin P. Edwards, Department of Cell Biology and Molecular Genetics and the Maryland Pathogen Research Institute, University of Maryland, College Park, Maryland 20742, USA. Nat Rev Immunol. 2008 December; 8(12): 958–969. doi: 10.1038/nri2448.