Validation of a Laparoscopic Ferromagnetic Technology-based Vessel Sealing Device and Comparative Study to Ultrasonic and Bipolar Laparoscopic Devices

Abstract

Introduction. Ferromagnetic heating is a new electrosurgery energy modality that has proven effective in hemostatic tissue dissection as well as sealing and dividing blood vessels and vascularized tissue. The purpose of this study was to evaluate a ferromagnetic-based laparoscopic vessel sealing device with respect to sealing and dividing vessels and vascularized tissue and to compare performance against current vessel sealing technologies.

Materials and Methods. A laparoscopic vessel sealing device, Laparoscopic FMsealer (LFM), was studied for efficacy in sealing and dividing blood vessels and comparative studies against predicate ultrasonic, Harmonic Ace+(US), and/or bipolar, LigaSure 5 mm Blunt Tip and/or Maryland (BP), devices in vivo using a swine model and in vitro for comparison of seal burst pressure and reliability. Mann-Whitney and Student t test were used for statistical comparisons.

Results. In division of 10 cm swine small bowel mesentery in vivo, the laparoscopic FMsealer [12.4±1.8 sec (mean±SD)], was faster compared with US (26.8±2.5 s) and BP (30.0±2.7 s), P<0.05 LFM versus US and BP. Blinded histologic evaluation of 5 mm vessel seals in vivo showed seal lateral thermal spread to be superior in LFM (1678±433 μm) and BP (1796±337 μm) versus US (2032±387 μm), P<0.001. In vitro, seal burst strength and success of sealing 2 to 4 mm arteries were as follows (mean±SD mm Hg, % success burst strength >240 mm Hg): LFM (1079±494 mm Hg, 98.1% success) versus BP (1012±463, 99.0%), P=NS. For 5 to 7 mm arteries: LFM (1098±502 mm Hg, 95.3% success) versus BP (715±440, 91.8%), P<0.001 in burst strength and P=NS in % success. Five 60 kg female swine underwent 21-day survival studies following ligation of vessels ranging from 1 to 7 mm in diameter (n=186 total vessels). Primary seal was successful in 97%, 99% including salvage seals. There was no evidence of postoperative bleeding at sealed vessels at 21-day necropsy.

Conclusion. The Laparoscopic FMsealer is an effective tool for sealing and dividing blood vessels and vascularized tissue and compares favorably to current technologies in clinically relevant end points.This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal. https://creativecommons.org/licenses/by-nc-nd/4.0/.