Aaron J Wille, BS1, Emily Speer, MD2, Simon Chow3, Chet Hammill, MD4, Christy M Dunst, MD4, Kevin M Reavis, MD4, Lee L Swanstrom, MD4. 1The Foundation for Surgical Innovation and Education, 2Providence Portland Medical Center, 3Legacy Good Samaritan Hospital, 4The Oregon Clinic – GMIS
Voyant™ from Applied Medical, is an emerging laparoscopic electrosurgical vessel sealing and cutting device which recently received FDA approval for use in human subjects. It is designed to allow for rapid sealing, coagulation, and transaction of vessels from 0.0-7.0mm in maximal diameter.
Two 5mm blunt tip laparoscopic bipolar electrosurgical devices, LigaSure™ (LS)(Covidien, Dublin, IRL) and Voyant™ (VT)(Applied Medical, Rancho Santa Margarita, CA, USA) were evaluated using eight porcine models. Vessels ranging from 0.0-7.0mm were cut and sealed with a combined study total of of four hundred and two device activations. The devices were compared by measurements of bursting pressure, vessel sealing time, tissue fusion, thermal spread, thermal radiation, and jaw force, as well as subjective user assessments. The bipolar energy generators were configured at comparable settings for the entirety of the study. Two sample independent t-test statistical analyses were performed.
Twenty-two arterial vessels of various sizes were sealed and cut with each device and used to determine bursting pressures. The mean vessel bursting pressures were found equivalent between the devices (LS=542.54mmHg, VT=570.74mmHg, p=0.7461). The time interval to achieve maximal temperature trended shorter (3.27s vs 4.60s, p=0.0751) and vessel sealing time was found faster with LigaSure™ when compared to Voyant™ (2.96s vs 3.10s, p=0.0308). The Voyant™ device tip was found to reach a higher mean maximal temperature (103.08 vs 96.24, p=0.0413), and cooled to a baseline temperature of 50°C at an rate equivalent to that of LigaSure™. Jaw force measured in the locked position was found significantly higher with LigaSure™ (4.44N/cm2 vs 3.90N/cm2, p<.0001). Histological analysis found equivalence in quality of luminal fusion and length of thermal spread. Voyant™ was found to fuse a shorter length of vessel lumen (p=0.0454). User assessment questionaires found no significant difference in ergonomics, dissecting ability, or visual obscurity between the two devices.
LigaSure™ is well established in the literature as a safe and effective bipolar laparoscopic device for vascular sealing and dividing. This study finds that Voyant™ offers equivalent function and efficacy in numerous measures including sealed vessel bursting pressures, quality of luminal fusion, and length of thermal spread in vessels from 0.0-7.0mm in diameter. Surgeons noted equivalence in ergonomics, dissecting ability, and visual obscurity after using each device. LigaSure™ was found to be faster with a mean difference of 0.14 seconds in vessel sealing time which may be of clinical significance. Maximal temperature during sealing, length of luminal fusion, and jaw force measures were also found to have significant numerical differences though the clinical significance of these findings is uncertain.