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.