CorMatrix CanGaroo Secures International Approval for South America

CorMatrix Cardiovascular Inc. has received international approval from Argentina’s National Administration of Drugs, Foods and Medical Devices (ANMAT) to market its 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 CanGaroo ECM Envelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices (CIED). The device was cleared for sale by the U.S. Food and Drug Administration in 2014 and is expected to receive a CE mark later this year for distribution in the European Union.

“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 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 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 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 Buenos Aires-based Demedic as the Argentinian distributor for its CanGaroo device. Founded in 1984, Demedic has worked with various international companies to bring the 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, pulmonary embolism and deep vein thrombosis treatment.

“It has been a privilege working with a medical device company like CorMatrix. 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,” said Demedic General Manager Cecilia Muñoz. “We also look forward to working with the CorMatrix team in bringing the latest technological developments to the Latin American market.”

Based in Atlanta, Ga., CorMatrix Cardiovascular was founded in 2001 as a privately held medical device company dedicated to developing and delivering biomaterial devices that harness the body’s ability to repair damaged cardiovascular tissues. CorMatrix ECM is designed for a variety of cardiovascular indications, and has U.S. clearance and European approval (with a CE Mark) for its ECM technology as an implant for pericardial closure, cardiac tissue repair, as well as clearance for carotid repair.