Aziyo Biologics has secured the US Food and Drug Administration (FDA) clearance for its CanGaroo Envelope device, to be used with implantable neurostimulator devices.
CanGaroo is a natural extracellular matrix (ECM) envelope that is designed to securely hold both cardiac implantable electronic devices (CIED) and implantable neurostimulators to create a stable environment following implantation. In addition to previously permitted use with pacemakers, defibrillators and other CIEDs, the FDA clearance for CanGaroo has been expanded to include vagus nerve, deep brain and sacral nerve stimulators as well as spinal cord neuromodulators.
The University of Florida Jacksonville Electrophysiologist John N. Catanzaro said: “Products such as the CanGaroo Envelope have become invaluable to electrophysiologists in helping reduce some of the complications associated with implantable devices while maintaining a more natural type of healing process.
“Expanding use to the field of neurostimulation will greatly benefit both subsets of patients who require these devices.”
Aziyo Biologics president and CEO Ron Lloyd said: “CanGaroo has been used by electrophysiologists since 2014 to improve patient outcomes in CIED procedures and we’re excited to now expand this offering to neurosurgeons as well.
“We are committed to driving the tremendous potential of our regenerative medicine products to make positive advances for patients and the professionals and organizations that serve them.”
Source: Company Press Release