†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), and cold knife (125 mL).
‡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).
§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.
1. Based on internal test report #RE000036877, Data collected during 17 procedures for product introduction. April–June 2017.
2. 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.
3. Lachanas VA, Prokopakis EP, Bourolias CA, et al. LigaSure™ versus cold knife tonsillectomy. Laryngoscope. 2005;115(9):1591–1594.
4. Based on internal test report #RE00015788, Tissue testing. March 23, 2017.
5. 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.
6. 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.
7. Based on internal test report #RE00073873 and #RE00079704, Independent surgeon and nurse feedback collected during Medtronic-sponsored labs. January and February 2017.
8. 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.
9. 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.
10. 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.
11. BiZact™ Tonsillectomy Device [instructions for use]. Boulder, CO: Medtronic; 2017.
12. Based on internal test report #RE00077022, Porcine testing: probability of burst ≥ 360 mm Hg is ≥ 96.1%. Jan. 9–10, 2017.
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