Conclusions:
This pre-clinical study demonstrated several advantages of using SIS ECM
envelopes to wrap clinically relevant CIEDs during subcutaneous
implantation. Compared to CIEDs alone without envelopes, procedures
utilizing CanGaroo Envelopes promoted formation of thinner connective
tissue bands and stimulated significantly higher rates of
neovascularization, while avoiding tissue necrosis. The study supported
the hypothesis that the CanGaroo ECM Envelopes steadily remodel and are
replaced by native, organized collagen over time that is free of
mineralization. This optimized tissue regeneration contributed to a
five-fold reduction in CIED flipping within the subcutaneous pocket
through stabilization by CanGaroo Envelopes. This study bolsters and
compliments existing in vivo and clinical data that show CanGaroo
Envelopes provide a superior pro-remodeling microenvironment for
creation of healthy and fully vascularized tissue, which safely secures
devices in place and improves the outcomes of device upgrades or
revision surgeries.