Evaluation of the safety, efficacy, and versatility of a new surgical energy device (THUNDERBEAT) in comparison with Harmonic ACE, LigaSure V, and EnSeal devices in a porcine model. 4545 Creek Road Cincinnati, Ohio 45242 Re: K172580 Trade/Device Name: ENSEAL X1 Tissue Sealers Regulation Number: 21 CFR 878. Evaluation of the novel bipolar vessel sealing and cutting device BiCision® in a porcine model. Ethicon Endo-Surgery, LLC Ryoji Sakai Manager Regulatory Affairs Ethicon Endo-Surgery, Inc. Szyrach MN, Paschenda P, Afify M, Schäller D, Tolba RH. Encuentre toda la información del producto: pinza laparoscópica ENSEAL® de la empresa Ethicon. Poster presented at: 2011 Society of American Gastrointestinal and Endoscopic Surgeons' Annual Meeting March 30–ApSan Antonio TX Collagen to elastin ratio in functionally discreet human cadaver vasculature predicts burst pressure of arteries sealed with a bi-polar sealing device. Collagen-elastin ratio predicts burst pressure of arterial seals created using a bipolar vessel sealing device in a porcine model. The histologic results of the aorta segments (ie, a low collagen-elastin ratio) may be the cause of the low bursting pressures.īursting pressure Collagen Elastin Enseal Porcine aorta Vessels. These vessels also demonstrated a higher rate of failure to seal. One-way analysis of variance did not show any significant difference between vessel diameters grouped by size (P=.517), and neither did the Scheffe post hoc test when comparing diameter with bursting pressure 31% of specimens failed to seal.īursting pressures are low and inconsistent after tissue sealing with the Enseal device in porcine vessels>7 mm. The Pearson test showed a negative correlation between vessel diameter and bursting pressure (P=.25).
Enseal ethicon endo surgery generator#
De instrumenten zijn bipolaire elektrochirurgische instrumenten voor gebruik met de Generator G11 (GEN11). De ENSEAL G2 articulerende weefselafdichters zijn gendiceerd voor bipolaire coagulatie en mechanische transsectie van weefsel tijdens laparoscopische en open ingrepen. The median diameter was 14 mm (range, 7-18) and bursting pressure was 85 mm Hg (range, 24-650). ENSEAL en I-BLADE zijn handelsmerken van Ethicon Endo-Surgery. Ninety samples of 5-cm aorta segments were used to assess bursting pressure. Title: ENSEAL G2 Articulating Tissue Sealer Brochure 159348-201116 Created Date: 11:44:10 AM. ENSEAL® G2 Articulating Curved ENSEAL® G2 Articulating Straight Ethicon Energy Solutions. One-way analysis of variance was used to determine differences between the groups of vessels on the basis of their diameter. All ENSEAL® and HARMONIC® devices are compatible with the Ethicon Endo-Surgery Generator. The bivariate Pearson correlation was used to determine the relationship between diameter and bursting pressure. The ETHICON ENDO-SURGERY Generator combines advanced technology, multifunctionality and touchscreen simplicity. The opposite end was attached to a pressure-testing device to measure pressures at leak or bursting. A 5- to 6-cm segment of aorta was sealed using the Enseal device.
The lumbar aortas of pigs that were euthanized for unrelated procedures were harvested. The Enseal (Ethicon Endo-Surgery, Blue Ash, Ohio) tissue-sealing device has proven efficacy for ligation of vessels7 mm.
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