Aziyo Biologics, out of Silver Springs, Maryland, won FDA clearance for its CanGaroo Envelope to be used with implantable neurostimulators. It has previously been cleared only for encapsulating implantable cardiac devices such as pacemakers and defibrillators.
The CanGaroo Envelope is, contrary to what its name may imply, is a porcine extracellular matrix, essentially pig’s tissue with all of its cells removed. Small intestinal submucosa of pigs is carefully harvested and put through a special process that preserves the structural strength of the material without posing any chance of rejection.
When a device is implanted within the CanGaroo Envelope, the envelope helps to keep it in place. Over time, the envelope usually revascularizes and turns into native tissue while creating an open space in which the implant resides. Because the implant is not completely in contact with nearby tissues, it may be easier to remove if necessary.
Electronic stimulators are now common for conditions such as chronic pain, Parkinson’s, and even depression, and now they can benefit from the same protective technology that the CanGaroo Envelope has offered to cardiac implants.
“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,” said Ron Lloyd, president and Chief Executive Officer of Aziyo Biologics. “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.”
Product page: CanGaroo Envelope…
Via: Aziyo…