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

Area of Science:

• Surgical Technology
• Medical Devices
• Vascular Surgery

Background:

• LigaSure™ devices are utilized for sealing blood vessels during surgical procedures.
• Early LigaSure™ devices, such as Atlas and Dolphin Tip, have established records of clinical performance.
• Advancements in surgical device technology aim to improve efficiency and safety.

Purpose of the Study:

• To compare the performance of the new LigaSure™ XP Maryland Jaw Sealer/Divider (XP Maryland) against two earlier LigaSure™ devices: LigaSure Atlas™ (Atlas) and LigaSure™ Dolphin Tip (Dolphin Tip).
• To evaluate specific performance metrics including seal times, burst pressures, and rates of procedural complications.

Main Methods:

• Ex vivo bench testing on porcine renal arteries assessing burst pressures, seal times, sticking, incomplete cuts, and charring.
• In vivo acute testing on a porcine model evaluating thermal spread, seal times, hemostasis, sticking, and incomplete cuts.
• Comparative analysis between the XP Maryland and the Atlas and Dolphin Tip devices.

Main Results:

• Ex vivo and in vivo studies showed significantly faster mean seal times for XP Maryland compared to both Atlas and Dolphin Tip.
• XP Maryland demonstrated fewer incomplete cuts and sticking incidents compared to the earlier devices in ex vivo and in vivo tests.
• Atlas exhibited a statistically higher average burst pressure than XP Maryland ex vivo; XP Maryland showed less lateral thermal spread in vivo.

Conclusions:

• The XP Maryland device exhibits consistent and reliable performance, comparable to earlier LigaSure™ models.
• XP Maryland presents improved performance characteristics, including faster sealing and fewer complications, potentially enhancing procedural efficiency and surgical safety.