www.fdanews.com/articles/189362-aziyos-bioscaffold-cleared-by-fda-for-expanded-use

Aziyo’s Bioscaffold Cleared by FDA for Expanded Use
November 30, 2018
The FDA has granted 510(k) clearance for Aziyo’s CanGaroo envelope, a naturally occurring bioscaffold used to hold cardiac implantable electronic devices (CIEDs).
The bioscaffold conforms to the implantable device to provide a stabilized environment for CIEDs like pacemakers and defibrillators after implantation.
The device can help to improve patient comfort, reduce device migration and make device removal easier for exchanges or revisions.