New Bipolar Electrosurgical Vessel Sealing Device Provides Improved Performance and Procedural Efficiency.

IF 1.5 Q4 ENGINEERING, BIOMEDICAL Medical Devices-Evidence and Research Pub Date : 2025-01-25 eCollection Date: 2025-01-01 DOI:10.2147/MDER.S498873

Rheagan Chambers, Danielle Sarno, Susan Roweton

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Abstract

Purpose: This study compared the performance of the new LigaSure™ XP Maryland Jaw Sealer/Divider (XP Maryland) to that of LigaSure Atlas™ (Atlas) and LigaSure™ Dolphin Tip (Dolphin Tip), two early LigaSure™ (LigaSure) devices characterized by consistent and reliable clinical performance.

Methods: Ex vivo bench testing on porcine renal arteries compared burst pressures, seal times, and rates of sticking, incomplete cuts, and charring between XP Maryland and Atlas and between XP Maryland and Dolphin Tip. In vivo acute testing on a porcine model compared thermal spread, seal times, and rates of hemostasis, sticking, and incomplete cuts between XP Maryland and the two early LigaSure devices.

Results: Ex vivo, XP Maryland showed a significantly faster mean seal time compared to Dolphin Tip (P < 0.0001) and Atlas (P < 0.0001). XP Maryland had fewer incomplete cuts than Dolphin Tip (P < 0.0001) and fewer sticking incidents than Atlas (P = 0.0019). Atlas had a statistically higher average burst pressure compared to XP Maryland (P < 0.0001). As with ex vivo results, XP Maryland had a significantly faster mean seal time in vivo compared to Dolphin Tip (P = 0.0168) and Atlas (P < 0.0001). Other in vivo results showed XP Maryland had fewer incomplete cuts compared to Dolphin Tip (P < 0.0001) and statistically less lateral thermal spread than Atlas (P = 0.0010). For all other ex vivo and in vivo performance characteristics, no statistically significant differences were found between XP Maryland and the other devices.

Conclusion: The study demonstrated the consistent and reliable performance of XP Maryland and the two early LigaSure devices. In addition, the studies showed XP Maryland has some improved performance characteristics when compared to Atlas and Dolphin Tip that may result in improved procedural efficiency and may reduce potential surgical risks.

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新型双极电外科血管封堵装置提高了性能和手术效率。

目的：本研究比较了新型LigaSure™XP Maryland颌密封/分隔器（XP Maryland）与LigaSure Atlas™（Atlas）和LigaSure™Dolphin Tip （Dolphin Tip）的性能，这两种早期LigaSure™（LigaSure）设备具有一致和可靠的临床性能。方法：对猪肾动脉进行体外实验，比较了XP Maryland与Atlas、XP Maryland与Dolphin Tip之间的破裂压力、密封时间、粘连率、不完全割伤率和炭化率。在猪模型上进行的体内急性试验比较了XP Maryland和两种早期LigaSure设备之间的热扩散、密封时间、止血率、粘附和不完全割伤。结果：与Dolphin Tip （P < 0.0001）和Atlas （P < 0.0001）相比，XP Maryland在体外的平均密封时间显著缩短。XP Maryland的不完全切口比Dolphin Tip少（P < 0.0001），粘着事件比Atlas少（P = 0.0019）。Atlas的平均破裂压力比XP Maryland高（P < 0.0001）。与离体结果一样，XP Maryland的体内平均密封时间明显快于Dolphin Tip （P = 0.0168）和Atlas （P < 0.0001）。其他体内结果显示，XP Maryland与Dolphin Tip相比有更少的不完整切口（P < 0.0001），统计学上比Atlas更少的侧向热扩散（P = 0.0010）。对于所有其他离体和体内的性能特征，XP Maryland和其他设备之间没有统计学上的显著差异。结论：该研究证明了XP Maryland和两种早期LigaSure器械的一致和可靠的性能。此外，研究表明，与Atlas和Dolphin Tip相比，XP Maryland有一些改进的性能特征，可以提高手术效率，降低潜在的手术风险。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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