US-based medical equipment developer Cook Biotech has signed exclusive worldwide global licence agreements for the use of Aziyo Biologics’ Bio Envelope scaffold with neuromodulation devices.
The natural extracellular matrix (ECM) scaffold is designed to securely hold implantable devices by generating a stable environment after implantation.
It is built from a multi-laminate sheet of decellularised, non-crosslinked, lyophilised extracellular matrix (ECM) obtained from porcine small intestinal submucosa (SIS).
Intended to minimise the risk of device migration and erosion, the natural ECM scaffold is also expected to potentially enable device removal in case of exchange or revision in the future.
Both 510(k) Food and Drug Administration (FDA) cleared and CE-Marked, the Bio Envelope is currently available under the brand name CanGaroo in the US and other international markets for use with cardiac implantable electronic devices (CIEDs).
Aziyo Biologics Cardiovascular division general manager Andrew Green said: “When Aziyo purchased the CanGaroo brand and licence in 2017, we saw tremendous potential for the product outside the current CIED market in areas such as neuromodulation.
“This new agreement with Cook Biotech is another step towards our goal of expanding and growing our Bio Envelope franchise.”
Through the new agreement with Cook Biotech, the scaffold will be used with neuromodulation devices during various techniques such as deep brain, spinal cord and sacral nerve stimulation to address chronic pain. It will also be used in nerve stimulation to manage bladder, digestive, abdomen, as well as bowel movements.
Cook Biotech president Umesh Patel said: “We’re excited to see the continued expanded use of our proprietary ECM technology and its benefit to patients.”