Figure 3: Representative A) H&E and B) trichrome images of capsular tissue-Images show envelope resorption and capsule thickening over 2, 13 and 26 weeks in the presence of the ECM envelope. Images from pockets receiving CIEDs without envelopes showed similar connective tissue formation at 13 and 26 weeks.
Histology sections were also scored for neovascularization on a 0 to 4 point scale by an independent blinded pathologist (Table 1) . The CanGaroo ECM Envelope group had a significantly higher neovascularization average score of 2.1 compared to a mean of 1.7 in the CIED without envelope group (p<.05, Student’s t-test) . In either group, no significant mineralization was observed in the tissue. No necrotic tissue areas were observed, and only low levels of apoptotic cells normally seen in surgical sites were found.