MORE EFFICIENT TONSILLECTOMIES 1-4,

Transcription

1 MORE EFFICIENT TONSILLECTOMIES 1-4, A procedural solution from Valleylab energy, the BiZact device is designed for tonsillectomies Used in 17 cases, average procedure time for the BiZact tonsillectomy device was 9.35 minutes, compared to 14.8 (pediatric) and 20.5 (adult) minutes for electrocautery 3 and minutes for the Coblator * device. 4

2 TABLE OF CONTENTS Product Information Introduction 3 Technology Overview 4 Device Features 5 Device Performance 6 Materials Management Information Indications for Use 7 Product Request Form 8 Ordering Information 9 References 9 510(k) Clearance 10

3 3 Introduction LESS BLEEDING.2,5,6, MORE IDEAL OUTCOMES. We believe there is a better tonsillectomy procedure for surgeons and patients entrusted in their care. It s now possible with the BiZact tonsillectomy device, in surgeons hands. The BiZact tonsillectomy device: Reduces bleeding during surgery Provides faster setup and more efficient procedures 2,5,6, 1-4, With a 3 mm vessel-sealing indication7 and curved jaws that follow the shape of the tonsil bed, the BiZact device is designed specifically for tonsillectomy procedures. It s the latest surgical innovation from the Valleylab energy portfolio, borne out of our commitment to continually advance patient care, together. 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)6 and cold knife (73 ml)7 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)3 and the Coblator * device (16.32 minutes.4

4 4 Technology Overview LOW ENERGY LEVELS. HIGH CLINICAL VALUE. The BiZact device is powered by Valleylab energy platforms that deliver consistent and reliable seals BiZact device vs. monopolar electrosurgery 12 Mid-seal The BiZact device uses advanced bipolar energy to permanently seal vessels up to 3 mm. 7 It s powered by Valleylab energy platforms that: Continuously measure impedance of clamped tissue Appropriately adjust energy levels in real time to maintain the desired tissue effect Automatically stop energy delivery when the seal is complete The clinical result is seals withstand three times normal systolic blood pressure, 8, and minimal thermal damage to tissue. 9 The clinical benefit is less intraoperative blood loss 2,5,6, and more efficient procedures. 1-4, Patients may also experience less postoperative pain due to low thermal damage. 9-11, Post-seal Based on internal bench testing, probability of burst 360 mm Hg is 96.1%. 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) 6 and cold knife (73 ml) 7 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) 3 and the Coblator * device (16.32 minutes). 4 Low thermal damage has been shown in 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.

5 5 Device Features DESIGNED FOR TONSILLECTOMIES Seal and divide tonsil tissues in one step 12 cm shaft provides optimal access In line activation facilitates intuitive control and efficient sealing and transection Curved jaw follows the shape of tonsil bed Ergonomic handle ensures comfort in either hand FAST EASY SETUP 1,Ʊ Simple setup contributes to procedural efficiency and it s easier than the Coblator * device. 1 Ʊ 12 out of 12 surgeons and 13 out of 15 nurses surveyed agreed. Nurses are very happy with it. Dr. Eng Ooi Head of Otolaryngology Head and Neck Surgery Unit at Flinders Medical Centre and Associate Professor, Flinders University, Adelaide, Australia Feedback provided March 2017.

6 EFFICIENT AND EFFECTIVE 6 Device Performance NEW TECHNIQUE. BETTER RESULTS. The removal is so efficient in terms of vessel sealing that it s quite rare for us to have to actually do anything once the tonsil s removed. Compared to the Coblator * device, the BiZact tonsillectomy device: Offers easier setup Reduces intraoperative bleeding Dr. Ron J. Karni 1,Ʊ 2,5,6, Compared to an electrosurgical pencil, the BiZact tonsillectomy device provides: Less bleeding during surgery Significantly lower maximum external jaw temperature Significantly faster jaw cooldown time to 60 C 2,5,6, 12 Chief, Division of Head & Neck Surgical Oncology; Associate Professor, Department of Otorhinolaryngology Head & Neck Surgery University of Texas Medical School at Houston 12 Ʊ12 out of 12 surgeons and 13 out of 15 nurses surveyed agreed. 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)6 and cold knife (73 ml)7 Picrosirius Red (PSR) Stained Images13, BiZact device Damaged tissue is dark red and undamaged tissue is gold. Monopolar electrosurgery Coblator * device Damaged tissue and incomplete seal Damaged tissue and incomplete seal Vessel is completely occluded Hematoxylin and Eosin (H&E) Stained Images BiZact device Vessel is completely occluded Monopolar electrosurgery Vessel is not occluded Coblator * device Vessel is not occluded

7 INDICATIONS FOR USE The BiZact device is a bipolar instrument intended for use in open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. The tissue fusion function of the device can be used on vessels (arteries and veins) and lymphatics up to and including 3 mm diameter. The BiZact device is indicated for use in open general surgical procedures. It is also indicated for adult ENT procedures, including tonsillectomy, for the ligation and division of vessels, tissue bundles and lymphatics 2-3 mm away from unintended thermally sensitive structures. The BiZact device has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use for these procedures.

8 PRODUCT REQUEST FORM I m requesting the following instrument to convert my practice to the BiZact tonsillectomy technique: BiZact tonsillectomy device (BZ4212A) The BiZact device: Reduces bleeding during surgery1-3, Provides efficiency throughout the procedure1,4-6, With a 3 mm vessel-sealing indication 7 and curved jaws that follow the shape of the tonsil bed, the BiZact device is designed specifically for tonsillectomy procedures. The minimal thermal damage to tissue may also help reduce postoperative pain for patients. 8-10, Thank you for reviewing this information. Please feel free to contact me if you have any questions. Sincerely, Additional comments: References 1. Based on internal test report #RE , Data collected during 17 procedures for product introduction. April June 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): Lachanas VA, Prokopakis EP, Bourolias CA, et al. LigaSure versus cold knife tonsillectomy. Laryngoscope. 2005;115(9): Based on internal test report #RE and #RE , Independent surgeon and nurse feedback collected during Medtronic-sponsored labs. January and February 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): 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): BiZact Tonsillectomy Device [instructions for use]. Boulder, CO: Medtronic; Based on internal test report #RE , Tissue testing. March 23, Wilson YL, Merer DM, Moscatello AL. Comparison of three common tonsillectomy techniques: a prospective randomized, double-blinded clinical study. Laryngoscope. 2009;119(1): 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): Based on internal test report #RE , Porcine testing. Jan. 9 10, Average intraoperative bleeding in 17 cases was 7.3 ml for BiZact device, compared to ml for Coblator * device and ml for electrocautery, 2 and 125 ml with cold knife. 3 Used in 17 cases, average procedure time for the BiZact tonsillectomy device was 9.35 minutes, compared to 14.8 (pediatric) and 20.5 (adult) minutes for electrocautery 5 and minutes for the Coblator * device. 6 Low thermal damage has been shown in 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. Based on internal bench testing, probability of burst 360 mm Hg is 96.1% Medtronic. All rights reserved. Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic. * Third party brands are trademarks of their respective owners. All other brands are trademarks of a Medtronic company. 06/2017 US [WF# ] BiZact device seals withstand 3X normal systolic blood pressure 11, 5920 Longbow Drive Boulder, CO medtronic.com/covidien

9 Ordering Information LET S OPTIMIZE TONSILLECTOMY PROCEDURES Contact your Medtronic sales representative today to trial the BiZact tonsillectomy device Ordering information BZ4212A, six per case medtronic.com/bizact References 1. Based on internal test report #RE and #RE , Independent surgeon and nurse feedback collected during Medtronic-sponsored labs. January and February Based on internal test report #RE , Data collected during 17 procedures for product introduction. April June 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): 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): 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): Lachanas VA, Prokopakis EP, Bourolias CA, et al. LigaSure versus cold knife tonsillectomy. Laryngoscope. 2005;115(9): BiZact Tonsillectomy Device [instructions for use]. Boulder, CO: Medtronic; Based on internal test report #RE , Porcine testing. Jan. 9 10, Based on internal test report #RE , Tissue testing. March 23, Wilson YL, Merer DM, Moscatello AL. Comparison of three common tonsillectomy techniques: a prospective randomized, double-blinded clinical study. Laryngoscope. 2009;119(1): 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): Based on internal test report #RE , Benchtop testing comparing the BiZact tonsillectomy device with the E1551X Valleylab Hex-locking blade electrode. March 23, Based on internal test report #RE , Histological image collection with BiZact BZ4212, a monopolar electrosurgical device E1551X, and the Coblator * Surgery System. March 30 and April 11, Photo credit Getty Images 2017 Medtronic. All rights reserved. Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic. * Third party brands are trademarks of their respective owners. All other brands are trademarks of a Medtronic company. 06/2017 US [WF# ] 5920 Longbow Drive Boulder, CO medtronic.com/covidien

10 510(k) CLEARANCE

11 510(k) CLEARANCE