ROSWELL, Ga.--(BUSINESS WIRE)--CorMatrix® Cardiovascular, Inc., a leading developer of biomaterials and medical devices, has received international approval from Argentina’s National Administration of Drugs, Foods and Medical Devices (ANMAT) to market the CorMatrix CanGaroo™ ECM® Envelope. The CorMatrix CanGaroo™ ECM® Envelope is intended to securely hold an implantable electronic device to create a stable environment when placed in the body. The devices that may be used with the CorMatrix CanGaroo™ ECM® Envelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices (CIED). The device was cleared for sale by the United States Food and Drug Administration (FDA) in 2014 and is expected to receive a CE mark later this year for distribution in the European Union (EU).
“This international approval for the CanGaroo™ draws us closer to our goal of making life changing technology available to patients around the globe,” CorMatrix’ CEO David Camp said. “We continue to drive the tremendous potential of our ECM® products to affect positive advances in cardiovascular medicine. We look forward to including more countries to the list of international approvals.”
CorMatrix® ECM® is a naturally occurring bioscaffold that enables the patient’s own cells to remodel and regrow new functional tissue structures in the body. The CorMatrix® CanGaroo™ is a soft, supple pocket having no sharp edges, which conforms to pacemakers and implantable cardioverter defibrillators (ICD) while stabilizing the pocket to restrict migration. The CorMatrix CanGaroo™ pouch vascularizes over time, re-growing a secure pocket, which also facilitates removal or revision during exchange of these CIEDs. CorMatrix’ ECM is also available for pericardial repair and reconstruction, cardiac tissue repair, and vascular repair.
The Company has selected service organization, Demedic as the Argentinian distributor for the CorMatrix CanGaroo device. Demedic is a service company focused on delivering the best and latest biomedical solutions to their clients, helping them improve their productivity and the quality of care they offer.
Founded in 1984, Demedic has worked with leading international companies to bring the best medical technology available to Argentina. Initially the company focused only on Cardiac Surgery products and services, but later expanded the scope of its offerings to other areas such as Temperature Management, Oncology, PE and DVT Treatment. Demedic has built a strong reputation as a trusted company and partner with their customers and other international organizations. The company is headquartered in Buenos Aires, Argentina, and currently centers its efforts on the regional market.
Demedic’s General Manager, Cecilia Muñoz commented, “It has been a privilege working with a medical device company like CorMatrix. As they continue to be at the forefront of regenerative medicine, we look forward to being the first company to market the CanGaroo pacemaker envelope internationally and to delivering ECM technology through different subspecialties of medicine in Argentina. We also look forward to working with the CorMatrix team in bringing the latest technological developments to the Latin American Market.”
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 825 hospitals across the U.S. and has been implanted in over 110,000 cardiac procedures. Visit cormatrix.com for additional information.