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Minimally Invasive Therapies / Products / Vessel Sealing / BiZact™ Tonsillectomy Device

Overview

Less bleeding.([FOOTNOTE=Based on internal test report #RE000036877, Data collected during 17 procedures for product introduction. April–June 2017.],[ANCHOR=],[LINK=]),([FOOTNOTE=Roje Z, Racić G, Dogas Z, Pisac VP, Timms M. Postoperative morbidity and histopathologic characteristics of tonsillar tissue following Coblation™* tonsillectomy in children: a prospective randomized single-blinded study. Coll Antropol. 2009;33(1):293–298.],[ANCHOR=],[LINK=]),([FOOTNOTE=Lachanas VA, Prokopakis EP, Bourolias CA, et al. LigaSure™ versus cold knife tonsillectomy. Laryngoscope. 2005;115(9):1591–1594.],[ANCHOR=],[LINK=]),†
Less tissue damage.([FOOTNOTE=Based on internal test report #RE00015788, Tissue testing. March 23, 2017.],[ANCHOR=],[LINK=]),([FOOTNOTE=Wilson YL, Merer DM, Moscatello AL. Comparison of three common tonsillectomy techniques: a prospective randomized, double-blinded clinical study. Laryngoscope. 2009;119(1):162–170.],[ANCHOR=],[LINK=]),([FOOTNOTE=Jones DT, Kenna MA, Guidi J, Huang L, Johnston PR, Licameli GR. Comparison of postoperative pain in pediatric patients undergoing Coblation™* tonsillectomy versus cautery tonsillectomy. Otolaryngol Head Neck Surg. 2011;144(6):972–977.],[ANCHOR=],[LINK=])
More efficient tonsillectomy.1,([FOOTNOTE=Based on internal test report #RE00073873 and #RE00079704, Independent surgeon and nurse feedback collected during Medtronic-sponsored labs. January and February 2017.],[ANCHOR=],[LINK=]),([FOOTNOTE=Lee SW, Jeon SS, Lee JD, Lee JY, Kim SC, Koh YW. A comparison of postoperative pain and complications in tonsillectomy using BiClamp forceps and electrocautery tonsillectomy. Otolaryngol Head Neck Surg. 2008;139(2):228-234.],[ANCHOR=],[LINK=]),([FOOTNOTE=Omrani M, Barati B, Omidifar N, Okhovvat AR, Hashemi SA. Coblation™* versus traditional tonsillectomy: A double blind randomized controlled trial. J Res Med Sci. 2012;17(1):45-50.],[ANCHOR=],[LINK=]),([FOOTNOTE=Shah UK, Galinkin J, Chiavacci R, Briggs M. Tonsillectomy by means of plasma-mediated ablation: prospective, randomized, blinded comparison with monopolar electrosurgery. Arch Otolaryngol Head Neck Surg. 2002;128(6):672-676.],[ANCHOR=],[LINK=]),‡

The BiZact™ tonsillectomy device allows surgeons to remove tonsils efficiently, with less bleeding1-3,† and minimal tissue damage.4-6 So patients may experience less pain after surgery.4-6,§

The BiZact™ tonsillectomy device is the right tool for the job — and it makes all the difference.

A procedural solution from Valleylab™ energy, the BiZact™ tonsillectomy device features:

  • 12 cm shaft for access 
  • Curved jaw that follows the shape of tonsil bed
  • Intuitive controls to seal and divide tissue and vessels up to 3 mm in diameter([FOOTNOTE=BiZact™ Tonsillectomy Device [instructions for use]. Boulder, CO: Medtronic; 2017.],[ANCHOR=],[LINK=])
  • Ergonomic handle for comfort in both hands

Features

From a fast and easy setup7,₤ to reliable seals that reduce intraoperative bleeding,1-3,†,([FOOTNOTE=Please refer to RE00077022_A RPT_Ver_BZ4212 Bench Burst report],[ANCHOR=],[LINK=])  the BiZact™ device improves efficiency throughout procedures.1,7-10,‡ With a low energy profile and minimal tissue damage,4-6-([FOOTNOTE=Please refer to RE00011247_A RPT_BZ4212 Thermal Profile report],[ANCHOR=],[LINK=]) patients may also experience less pain after surgery.4-6,§,([FOOTNOTE=Please refer to 1688207 BiZact Experience Global R2],[ANCHOR=],[LINK=])

LOW ENERGY LEVEL.
HIGH CLINICAL VALUE.

The BiZact™ device is an advanced bipolar tissue sealer and divider. It’s powered by Valleylab™ energy platforms that:

  • Measure impedance of clamped tissue 
  • Adjust energy output to create a permanent seal
  • Automatically stop energy delivery when the seal is complete

As a result of this technology, the BiZact™ device:

  • Offers fast and easy setup7,₤
  • Produces seals that withstand 3x normal systolic blood pressure([FOOTNOTE=Based on internal test report #RE00077022, Porcine testing: probability of burst ≥ 360 mm Hg is ≥ 96.1%. Jan. 9–10, 2017.],[ANCHOR=],[LINK=])
  • Reduces bleeding during surgery1-3,†
  • Improves procedural efficiency1,7-10,‡
  • Minimises tissue damage,4-6 which may reduce postoperative pain4-6

  • † Average intraoperative bleeding in 17 cases was 7.3 mL for BiZact™ device, compared to published literature results for Coblator™* device (10.83 mL) and electrocautery (27.08 mL),2 and cold knife (125 mL).3

  • ‡ Average procedure time in 17 cases for the BiZact™ tonsillectomy device was 9.35 minutes, compared to published literature results for electrocautery (14.8  minutes pediatric, 20.5 minutes adult)8 and the Coblator™* device (16.32 minutes).9

  • § Low thermal damage has been shown in published studies to result in less postoperative pain. The Bizact™ device has been shown to produce <1 mm thermal spread, but has not been directly evaluated for pain reduction.

  • ₤ 12 out of 12 surgeons and 13 out of 15 nurses surveyed agreed.

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