CorMatrix announced that it 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. 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,” David Camp, CorMatrix’ CEO says. “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 stabilising the pocket to restrict migration. The CorMatrix CanGaroo pouch vascularises over time, re-growing a secure pocket, which also facilitates removal or revision during exchange of these cardiac implantable electronic devices. CorMatrix’ ECM is also available for pericardial repair and reconstruction, cardiac tissue repair, and vascular repair.
The CorMatrix has selected service organisation, Demedic as the Argentinian distributor for the CorMatrix CanGaroo device.