CorMatrix Cardiovascular CanGaroo ECM Envelope Receives CE Mark Approval
CorMatrix® CanGaroo® ECM® Envelope Receives CE Mark Approval
ROSWELL, Ga.--(BUSINESS WIRE)--
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 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 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.
About CorMatrix
CorMatrix® Cardiovascular, Inc. is a privately held medical device company dedicated to developing and delivering innovative 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, Georgia, 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 U.S. and has been implanted in over 145,000 cardiac procedures. Visit cormatrix.com for additional information.
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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20160628005246/en/
Contact:
CorMatrix Cardiovascular, Inc.
Patricia Cuomo, 470-514-4042
pcuomo@cormatrix.com
ROSWELL, Ga.--(BUSINESS WIRE)--
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 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 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.
About CorMatrix
CorMatrix® Cardiovascular, Inc. is a privately held medical device company dedicated to developing and delivering innovative 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, Georgia, 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 U.S. and has been implanted in over 145,000 cardiac procedures. Visit cormatrix.com for additional information.
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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20160628005246/en/
Contact:
CorMatrix Cardiovascular, Inc.
Patricia Cuomo, 470-514-4042
pcuomo@cormatrix.com