Objective: Development of ultrasonic technology in surgical devices includes mechanisms of monitoring and adjusting energy delivery to target tissues for the purpose of limiting thermal spread. The objective of the current study was to evaluate performance of a new Adaptive Tissue Technology algorithm, designed to enhance thermal management in the HARMONIC 1100 Shears. Methods: The HARMONIC 1100 Shears were evaluated with bench-top and in vivo preclinical (porcine) analyses for tissue thermal spread, blade heat, transection speed, hemostasis and vessel sealing performance. Testing was performed in parallel with the current production HARMONIC HD 1000i Shears to confirm non-inferiority of the new Adaptive Tissue Technology algorithm. Results: Bench top analysis revealed significantly lower average maximum blade temperatures for HARMONIC 1100 compared to HARMONIC HD 1000i as well as HARMONIC ACE+ 7 Shears with Advanced Hemostasis. Thermal spread, transection speeds, and burst pressure tests of excised porcine carotid arteries did not show a statistical difference between HARMONIC 1100 and HD 1000iShears. In vivo analysis of hemostasis following sealing/transection of various blood vessels in acute porcine testing demonstrated similar efficacy for HARMONIC 1100 and HD 1000i Shears. Likewise, tissue lateral thermal damage showed no statistical difference between the new and previous generation Harmonic device in the porcine model. Conclusion: The new Adaptive Tissue Technology in HARMONIC 1100 Shears allows for reduced maximum blade temperatures while providing effective hemostasis, sealing strength, transection speed, and limited thermal damage.
Background: Advanced bipolar devices are increasingly popular for cutting and coagulating vessels up to 7 mm in diameter. In this study, a recently introduced device with improved ergonomics, the ENSEAL® X1 Large Jaw (X1) was compared to another commercially-available advanced bipolar device.
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