Implantation of medical devices such as pacemakers and
defibrillators can cause significant damage to nearby tissue, while afterwards
the implants can move around, causing more problems.
With this in mind, CorMatrix
has developed a special bioscaffold known as CanGaroo ECM Envelope that holds a
cardiac implantable electronic device (CIED) in order to create a stable
environment when implanted in the body.
The company, which develops novel biomaterials, announced
that they have received U.S. Food and Drug Administration (FDA) clearance to
market the CanGaroo ECM Envelope for use with cardiac implantable electronic
devices (CIED's) including pacemakers and implantable cardioverter
The special bioscaffold is a "pouch" which holds a
CIED after implantation. It is constructed from a multi-laminate sheet of
decellularized, non-crosslinked, lyophilized extracellular matrix (ECM )
derived from porcine small intestinal submucosa. The pouch will be provided in
four sizes to fit an array of device types and sizes.
The company claims that the first human implant of the
CanGaroo ECM Envelope was performed by Dr. Bruce Wilkoff, Director of Cardiac
Pacing and Tachyarrhythmia Devices at Cleveland Clinic.
Pre-clinical testing of the CanGaroo ECM Envelope
demonstrated that it was replaced with a vascularized tissue pouch at 90 day
follow up that isolated the CIED within the normal tissue. In pre-clinical
trials, the new vascularized tissue allowed for easy removal of the CIED.
The decellularized matrix material serves as a bioscaffold
to allow vascular ingrowth from adjacent tissues to deliver progenitor cells
and nutrients to the matrix, which then differentiate into tissue-specific
cells and structures.
The ECM material is gradually replaced as the patient's own
cells reinforces and rebuilds the diseased or damaged site. During repair, the
matrix is naturally degraded and resorbed, leaving remodeled functional tissue
where damaged or injured tissue would normally be expected.
The safety of extracellular matrices has been well
established in a number of different clinical applications. Since 1999, an
estimated two million patients worldwide have received an extracellular matrix