Evaluation of EnSeal®, an adaptive bipolar electrosurgical tissue-sealing device

Abstract

Relatively few, and inconsistent, data are available in the literature about the properties of EnSeal®, an electrosurgical tissue-sealing device. For this reason, we conducted control safety tests on experimental pigs. The mean burst pressure of sealed vessels (2-7 mm in diameter) proved to be 873.89 ± 120.57 mmHg (n = 60). Surface temperature increased to 69.25 ± 0.98 °C in average (n = 22). The mean diameter of the collateral microscopic thermal injury zone was found to be 0.28 ± 0.04 mm, and it did not show significant differences among the groups of tissues studied (n = 183). During our studies, the device worked reliably and met the relevant requirements in all cases. It can be established that EnSeal® enables high-safety clinical interventions at high blood pressure values, in different tissues and even at sites adjacent to heat-sensitive tissues, and thus it paves the way for new operative solutions in both human and veterinary surgery. In our opinion, the discrepancies between data reported in the literature arise from differences in the design of studies and in the designated limit values. To ensure standardisation, we recommend the use of the nitroblue-tetrazolium chloride/lactate dehydrogenase (NBTC/LDH) enzyme histochemical technique for studying thermal injury induced by the different performance levels and application times of devices operating with electromagnetic energy.