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Compression injury of the circular stapler for gastrointestinal end-to-end anastomosis: preliminary in-vitro study. The effect of tissue compression on circular stapler line failure. Ethicon, SCN052882B Summary of Design Intent for Ethicon Circular Stapler to support market claims, Jan 2021, Data on file (114092-201126 EMEA)Ģ. Benchtop testing comparing mean peak sound intensity during firing. ¶ For use with updated codes (B codes): Benchtop testing comparing average vibration measured as mean vectorial acceleration during firing. § Benchtop testing on porcine colon, comparing means of 1.214mm for Ethicon CDH29B (n=23) to 10.240mm for Medtronic EEA28 (n=23), p<0.001 for tissue displacement, resulting in 8.4 times less longitudinal displacement during closure for CDH29B, and comparing means of 0.022 for Ethicon CDH29B (n=23) to 0.081 for Medtronic EEA28 (n=23), p=0.0016 for tissue strain, resulting in 3.7 times less circumferential strain during opening for CDH29B. ‡ Benchtop testing of force to fire of Ethicon 25mm devices, comparing means of 70.92 in*lbf for CDH25B (n=32) to 111.28 in*lbf for CDH25A (n=32), p<0.05. Unacceptable injury was defined as cases where the damage exceeded half of the collagen thickness. 29 out of 88 with Medtronic fixed compression (EEA28 with green cartridge). † In-vitro collagen tissue model with Ethicon Circular Staplers, 19 out of 232 collagen tissues exhibited unacceptable tissue damage with adjustable compression (CDH29A), vs. * In a porcine model maximum intraluminal pressure of an anastomosis correlated most strongly with the compression of the tissue involved in the anastomosis.