Explore the resources below to learn about the benefits of the BiZact™ Tonsillectomy Device.
†As of Aug. 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™* and 27.08 for electrocautery [Roje] and 125 ml [Lachanas] with cold knife
1. Based on internal report RE00213922, Pediatric indication claims for the BiZact Tonsillectomy Device BZ4212A (memo). March 5, 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.
1. Based on internal test report #RE00003687, 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 #RE00073873 and #RE00079704, Independent surgeon and nurse feedback collected during Medtronic-sponsored labs. January and February 2017.
5. Based on internal test report #RE00077022, Porcine testing. Jan. 9–10, 2017.
6. Based on internal test report #RE00011247, Benchtop testing comparing the BiZact™ tonsillectomy device with the E1551X Valleylab™ Hex-locking blade electrode. March 23, 2017.
7. Based on internal test report RE00015788 collected during Medtronic-sponsored tissue testing conducted on March 23, 2017
8. 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.
9. 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.
10. Based on internal test report #RE00015788, Tissue testing. March 23, 2017.