Effectiveness and Usability of a Newly Designed Advanced Bipolar Tissue Sealer, ENSEAL X1 Curved Jaw Tissue Sealer

David W Singleton1, Crystal D Ricketts1*, Daniel Boguszewski2, John Cummings3, Kevin M Lewis3, Geisa Paulin-Curlee3, Monica Rivard4 and William Petraiuolo1

1Medical Affairs, Ethicon, Inc. 4545 Creek Road, Cincinnati, Ohio, USA
2Research and Development, Ethicon, Inc. 4545 Creek Road, Cincinnati, Ohio, USA
3Preclinical Research, Ethicon, Inc. 4545 Creek Road, Cincinnati, Ohio, USA
4Industrial Design Human Factors, Ethicon, Inc. 4545 Creek Road, Cincinnati, Ohio, USA

^*Correspondance to: Crystal D Ricketts 

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Abstract:

Aim: The objective of this work was to evaluate a new advanced bipolar sealer for vessel sealing
strength, hemostatic performance, lateral thermal spread, and overall useability in benchtop
analyses and preclinical surgical models.
Methods: Seal strength of ex vivo porcine vessels transected with the ENSEAL® X1 Curved Jaw Tissue
Sealer (EX1) and control bipolar sealers was assessed using splenic arteries, thyrocervical arteries,
and carotid arteries. In vivo effectiveness and tissue thermal effects were evaluated in acute and
chronic porcine models via transection of vessels and hemostasis assessments under normal blood
pressure conditions and during hypertensive challenge. Transected carotid arteries were evaluated
for lateral thermal spread. Device useability was tested by 31 surgeons.
Results: The overall mean burst pressures for ex vivo arteries were: 1055 mmHg for EX1, 825 mmHg
for the ENSEAL G2 Curved Tissue Sealer (EG2), 826 mmHg for LigaSure Maryland Jaw Open and
Laparoscopic Sealer/Divider with Nano-coating (LMJ), and 970 mmHg for LigaSure Blunt Tip
Open and Laparoscopic Sealer/Divider with Nano-coating (LBT); p<0.001 comparing EX1 with
EG2 or LMJ. For the acute in vivo transected arteries with EX1 (n=112) and EG2 (n=112), 100%
exhibited hemostasis immediately following transection and after a hypertensive challenge. Mean
lateral thermal spread was similar in carotid arteries transected with EX1 and EG2, (2.48 mm and
2.44 mm, respectively). The chronic in vivo transected arteries with EX1 (n=79), exhibited 98.7%
hemostasis immediately following transection and 100% after a hypertensive challenge at 30 ± 2
days. Evaluation of the EX1 in simulated clinical/porcine models indicated acceptable useability by
all participating surgeons.
Conclusion: The ENSEAL X1 Curved Jaw Tissue Sealer exhibited significantly higher vessel seal
strength compared to EG2 and LMJ, as well as non-inferior hemostasis and similar lateral thermal
spread relative to EG2. The useability of EX1 was rated acceptable by participating surgeons.

Keywords:

Tissue sealer; Vascular sealer; Advanced bipolar; Enseal; Liga Sure

Cite the Article:

Singleton DW, Ricketts CD, Boguszewski D, Cummings J, Lewis KM, Paulin-Curlee G, et al. Effectiveness and Useability of a Newly Designed Advanced Bipolar Tissue Sealer, ENSEAL X1 Curved Jaw Tissue Sealer. World J Surg Surgical Res. 2021; 4: 1304..