The BiZact™ tonsillectomy device is now the first and only tonsillectomy device in the U.S. with a pediatric indication.1,†
“It’s so effective both in hemostasis and in surgical performance, when it comes to time and blood loss.”
- Dr. Per Attner, Department of Oto-RhinoLaryngology, Sophiahemmet Hospital, Stockholm, Sweden
LEARN ABOUT SURGEONS’ EXPERIENCES USING THE BIZACT™ DEVICE. SEE IT IN ACTION.
The BiZact™ device has clinically proven benefits for you and your pediatric patients
Nearly eliminates intraoperative bleeding2-4,‡
Offers less time under anesthesia2,5,6,§
Provides reduced incidence of postoperative bleeding in pediatric tonsillectomy procedures7,8,Ω
Contact us for more information or to try the BiZact™ tonsillectomy device in your next pediatric case.
Together, we can help more patients find your practice. Patients and physicians search our Physician Finder to find clinicians like you who have experience using the BiZact™ device and/or are experienced in tonsillectomy procedures. Would you like to add your information to the Medtronic Physician Finder? Please fill out the form below — and we’ll take care of the rest!
REFERENCES
† As of August 11, 2020, based on indications for use for electrosurgical cutting and coagulation device and accessories in the FDA 510(k) database over the last 10 years. The BiZact™ device is indicated for adult, children, and adolescent tonsillectomy procedures (3 years of age and above).
‡ Used in 48 cases, including adults (22+) US (18+) EU the use of the BiZact™ tonsillectomy device resulted in non-measurable bloodloss compared to published literature stating 10.83 ml for Coblator™*, 27.08 ml for electrocautery [Roje], and 125 ml [Lachanas] with cold knife.
§ Used in 48 cases, including adults (22+) US (18+) EU. Average procedure time for the BiZact™ tonsillectomy device was 7 min. compared to published literature stating 14.8 (pediatric) and 20.5 (adult) min. [Lee] for electrocautery and 27.3 min. [Omrani] for Coblator™*
Ω Used in 60 cases, including patients (age range 3–12yrs) in the U.S. There were no intra-operative or post-operative bleeding events, defined as bleeding events that required intervention compared to secondary post-operative hemorrhage rates in published literature of 6.3% for electrocautery, 4% for cold dissection, and 2.4% for coblation [Francis].
†† 12 out of 12 surgeons and 13 out of 15 nurses surveyed agreed.
‡‡ Based on internal bench testing, probability of burst ≥ 360 mm Hg is ≥ 96.1%.
1. Based on internal report #RE00213922, Pediatric indication claims for the BiZact™ tonsillectomy device BZ4212A (memo). March 6, 2020.
2. Karni, R., Attner, P. (2018). A prospective, multi-center, single arm, non-comparative pilot study of BiZact on adults undergoing tonsillectomy. Data on file. Study sponsored by Medtronic. ClinicalTrials.gov Identifier: NCT02876575
3. 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.
4. Lachanas VA, Prokopakis EP, Bourolias CA, et al. LigaSure™ versus cold knife tonsillectomy. Laryngoscope. 2005;115(9):1591–1594.
5. 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.
6. 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.
7. Brown, E. (2019). A prospective, multi-center, single arm study of BiZact™ on children undergoing tonsillectomy. Data on file. Study sponsored by Medtronic. ClinicalTrials.gov Identifier: NCT03266094
8. Francis D, Fonnesbeck C, Sathe N, McPheeters M, Krishnaswami S, Chinnadurai S. Postoperative bleeding and associated utilization following tonsillectomy in children: a systematic review and meta-analysis. Otolaryngol Head Neck Surg. 2017; 156(3):442-455.
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