The US Food and Drug Administration (FDA) has approved the use of Aziyo Biologics’ bioscaffold CanGaroo Envelope with implantable neurostimulator devices.
CanGaroo is an extracellular matrix (ECM) envelope that is developed to securely hold cardiac implantable electronic devices (CIED) after implantation.
It uses a multi-laminate sheet of decellularised, non-crosslinked, lyophilised ECM procured from porcine small intestinal submucosa (SIS). It becomes a vascularised pocket over time to expedite future removal or alterations.
The device was previously received 510(k) FDA clearance for use with pacemakers, defibrillators and other CIEDs. This latest clearance expands its use to spinal cord neuromodulators and vagus nerve, deep brain and sacral nerve stimulators.
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 organisations that serve them.”
The University of Florida’s 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.”