Jennwood Chen, MD1, Curtis R Jensen, MS2, Preston K Manwaring, MSEE, PhD2, Robert E Glasgow, MD1. 1University of Utah Hospitals, 2Domain Surgical Inc
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.
Methods: A laparoscopic vessel sealing device based on ferromagnetic heating, 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, LigaSureTM 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’s 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 to US (26.8 ± 2.5 sec) and BP (30.0 ± 2.7sec), p<0.05 LFM vs 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 mm) and BP (1796 ± 337 mm) vs US (2032 ± 387 mm), p<0.001. In vitro, seal burst strength and success of sealing 2-4 mm arteries were as follows (mean ± SD mmHg, % success burst strength >240 mmHg): LFM (1079 ± 494 mmHg, 98.1% success) vs BP (1012 ± 463, 99.0%), p=NS. For 5-7 mm arteries: LFM (1098 ± 502 mmHg, 95.3% success) vs 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 1-7 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 endpoints.
Presented at the SAGES 2017 Annual Meeting in Houston, TX.
Abstract ID: 84073
Program Number: ETP728
Presentation Session: Emerging Technology Poster
Presentation Type: Poster
