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Innovative technologies and expert solutions for Neck, Laryngeal, Facial, and Otologic surgery MANY SOLUTIONS. ONE MEDTRONIC. INSPIRATION. INNOVATION. INTEGRATION. Head and Neck Surgery

INSPIRATION. INNOVATION. INTEGRATION

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Page 1: INSPIRATION. INNOVATION. INTEGRATION

Innovative technologies and expert solutions for Neck, Laryngeal, Facial, and Otologic surgery

MANY SOLUTIONS. ONE MEDTRONIC.

INSPIRATION. INNOVATION. INTEGRATION.Head and Neck Surgery

Page 2: INSPIRATION. INNOVATION. INTEGRATION

HEAD & NECK SURGERY SOLUTIONS ADVANCING PATIENT CAREWe understand the unique challenges to treating head and neck disease. Together, we can find solutions. Our market-leading technologies help you give patients the best chance for successful surgery — and help protect quality of life.3,13,29

MEANINGFUL INNOVATIONHELPING YOU AND YOUR PATIENTSPatients need successful surgeries to treat diseases while preserving function. And you face pressure to improve outcomes, save cost, and stay abreast of medical trends. By combining our expertise, we can improve outcomes in head and neck surgery.3

Our surgical solutions are designed to help you treat head and neck diseases by:

§ REDUCING the risk of intraoperative nerve damage1,11

§ INCREASING operative efficiency and precision2

§ ENABLING better patient outcomes3

NECK SURGERYRLN, non RLN, EBSLN, and facial nerve injuries may result in:

§ Swallowing disorders4

§ Low self-esteem, emotional distress, and social isolation4,27

Inadvertent removal of healthy parathyroid glands or injury to parathyroid glands during thyroid procedures can lead to hypocalcemia which may:32

§ Cause numbness in fingers and toes, muscle cramps in legs and feet, irritability, and seizures.

§ Require treatment with Vitamin D for more than 6 months after operation.33

§ Increase mean incremental cost of care.34

FACIAL SURGERYFacial nerve injuries may result in:

§ Unilateral weakness of upper and lower face8

§ Diminished ability to close the eyelid30

§ Difficulties with chewing food30

§ Disordered lacrimation8 and salivation31

LARYNGEAL SURGERYThe impact of a voice disorder may result in:

§ Lower level of physical functioning5

§ Lower level of social functioning5

§ Lower level of vitality5

OTOLOGIC SURGERYInjuries to the facial nerve in common Otologic procedures may result in:

§ Facial paralysis8,9

§ Impact of quality of life8,9

Page 3: INSPIRATION. INNOVATION. INTEGRATION

NECK SURGERYRecurrent laryngeal nerve (RLN) injury is one of the most serious — and underestimated — complications of thyroid surgery.10

Intraoperative RLN monitoring aids in nerve preservation and is a risk-minimizing tool during neck dissections.1,11-13

Sonicision™ System

NIM™ EMG Tubes

APS™ Electrode LigaSure™ Exact Dissector

EndoSheath™ SystemPTeye™ Parathyroid Detection System NIM™ Stimulator Probes

NIM Vital™ Nerve Integrity Monitoring System

NIM Vital™ Nerve Integrity Monitoring System

§ Intraoperative nerve condition information to inspire surgical strategy1,11,26 and help improve patient outcomes3*

§ Proprietary technology that notifies you in real time of nerve condition — visually and audibly

§ Intelligent noise reduction technology that suppresses artifact events by 94.5% for a quieter experience28**

PTeye™ Parathyroid Detection System

§ Aids surgeons in the identification of parathyroid tissue by confirming parathyroid tissue already visually located by the surgeon real-time during thyroid and parathyroid surgery

§ 96% accurate in confirming the parathyroid gland

APS™ Electrode § Continuously monitors vagus/recurrent

laryngeal nerve in real time § Enables early detection and warning of

change in nerve function20

NIM™ EMG Endotracheal Tubes § Continuously monitors nerves in both vocal

cords during surgery § Helps reduce risk with NIM™ nerve

monitoring15,26

§ Maintains open airway for patient ventilation

EndoSheath™ System for Flexible Scopes

§ Disposable, protective sterile sheath § Eliminates need for high-level disinfection

between patients24

LigaSure™ Exact Dissector § One-step vessel sealing, atraumatic

grasping, cold cutting, and blunt dissection — all in one device

§ Powered by Valleylab™ FT10 energy platform

Sonicision™ Curved Jaw Cordless Ultrasonic Dissection System

§ Freedom from cords, which improves movement, mobility,18 and safety19 in any OR

§ 13 cm device, designed to enable greater visibility of the surgical field than a hemostat-style design25†

NIM™ Stimulator Probes § Stimulates nerves, assisting with locating

and mapping nerves in surgical field § Prass, Bipolar and Monopolar styles

†10 out of 13 surgeons surveyed after use agreed.

Page 4: INSPIRATION. INNOVATION. INTEGRATION

NIM Vital™ Nerve Integrity Monitoring System § Intraoperative nerve condition information to inspire surgical strategy1,11,26 and help improve

patient outcomes3*

§ Proprietary technology that notifies you in real time of nerve condition — visually and audibly § Intelligent noise reduction technology that suppresses artifact events by 94.5% for a quieter

experience28**

NIM™ Paired and Subdermal Electrodes § Records electric signals via NIM™ system

NIM™ Stimulator Probes § Stimulates nerves assisting with locating and mapping nerves in surgical field § Prass, Bipolar and Monopolar styles

FACIAL SURGERYEach patient’s facial nerve varies in location — identification and preservation of the facial nerve is a major challenge when performing parotidectomy.16

Facial nerve monitoring is a simple, effective adjunct method that is available to surgeons to assist with the functional preservation of the facial nerve during parotid surgery.17

NIM Vital™ Nerve Integrity Monitoring System

NIM™ Stimulator Probes

NIM™ Electrodes

Page 5: INSPIRATION. INNOVATION. INTEGRATION

StraightShot™ M5 Microdebrider and Laryngeal Blades § Comprehensive range of powered surgery tools for performing minimally invasive ENT

procedures § Multiple blades for airway lesions § Blade tips that rotate 360° to allow optimum access § Runs on IPC™ system

Shiley™ Laser Flex Oral/Nasal Tracheal Tube § Resistant to CO2 and KTP lasers22,23

§ Stainless steel, flexible, airtight

EndoSheath™ System for Flexible Scopes § Disposable, protective sterile sheath § Eliminates need for high-level disinfection between patients24

IPC™ System § Multispecialty surgical system with touchscreen control and auto handpiece recognition § Powers multiple Medtronic handpieces at once

LARYNGEAL SURGERYIntermediate or advanced laryngeal procedures may jeopardize the vocal cords.14

When it comes to the treatment of laryngeal cancer, a patient’s wishes are a significant element in every decision because of the wide variety of treatments available, the differences in how each treatment affects voice, swallowing, and quality of life.14

Shiley™ Laser Flex Tube EndoSheath™ System

StraightShot™ M5 Microdebrider and Laryngeal Blades

IPC™ Powered Surgery System

Page 6: INSPIRATION. INNOVATION. INTEGRATION

OTOLOGIC SURGERYIatrogenic injury to the facial nerve is one of the most devastating complications of ear surgery. Incidence of facial nerve injury in primary otologic procedures has been found to be as high as 1% and 4%. But in revision procedure, it was reported to be more than double when compared to primary operations.9

By stimulating proximal to the nerve’s site before and after the surgery, intraoperative nerve monitoring may help you verify nerve integrity prior to closing.12,15

NIM™ Stimulator Probes

Indigo™ Drill

NIM Vital™ Nerve Integrity Monitoring System

IPC™ Powered Surgery System

Stim Bur Guard

Visao™ Drill

NIM Vital™ Nerve Integrity Monitoring System

§ Intraoperative nerve condition information to inspire surgical strategy1,11,26 and help improve patient outcomes3*

§ Proprietary technology that notifies you in real time of nerve condition — visually and audibly

§ Intelligent noise reduction technology that suppresses artifact events by 94.5% for a quieter experience28**

Indigo™ High Speed Otologic Drill

§ High speed and ample torque for fast debulking

§ Improved surgical access and visibility in otologic spaces

§ Use with XL Tapered Burs and a variety of Medtronic Xomed™ burs

§ Powered by IPC™ or XPS Nexus™ systems

NIM™ Paired and Subdermal Electrodes

§ Records electric signals via NIM™ system

NIM™ Stimulator Probes § Stimulates nerves assisting with locating

and mapping nerves in surgical field with locating and mapping nerves in surgical field

§ Prass, Bipolar and Monopolar styles

IPC™ System § Multispecialty surgical system with

touchscreen control and auto handpiece recognition

§ Powers multiple Medtronic handpieces at once

Stim Bur Guard § Combines electric drill with stimulation for

nerve monitoring § Enables NIM Vital™ system to alert you of

bur proximity to facial nerve

Visao™ Otologic Drill § Compact handpiece with water-cooled

engine § Connection for continuous stimulation

enables nerve integrity monitoring during surgical procedures

ENT MR8™ High Speed Drill § Features latest Midas Rex® technology

to enable precise cutting and maximize visualization

§ Enhanced motor technology for longer drilling

§ Variable attachments feature fine exposure adjustments

ENT MR8™ High Speed Drill

NIM™ Electrodes

Page 7: INSPIRATION. INNOVATION. INTEGRATION

REFERENCES1. Dionigi G, et al. Why monitor the recurrent laryngeal nerve in thyroid surgery? J Endocrinal Invest. 2010; 33: 819-822.2. Sari S, Erbil Y, Sumer A et al. Evaluation of recurrent laryngeal nerve monitoring in thyroid surgery. Int J Surg 2010;8(6):474-478.3. Schneider R, Sekulla C, Machens A, Lorenz K, Nguyen P, Dralle H. Postoperative vocal fold palsy in patients undergoing thyroid surgery with continuous or intermittent

nerve monitoring. BJS. 2015; 102:1380-1387.4. Goyal N, Meyers A. Thyroidectomy. Updated May 8, 2018. https://emedecine.medscape.com/article/1891109-overview#a1 (Accessed 8-18-2020).5. Benninger M., Anoop S., Gardner G. et al. Assessing Outcomes for Dysphonic Patients. Journal of Voice 1998; Vol. 12, No. 4, pp. 540-550.6. Chandrasekhar S, Randolph G, Seidman M et al. MD Clinical Practice Guideline: Improving Voice Outcomes after Thyroid Surgery. Otolaryngology–Head and Neck Surgery,

148(6S) S1–S37 2013.7. McHorney C, Martin-Harris B, Robbins J, Rosenbek J. Clinical Validity of the SWAL-QOL and SWALCARE Outcome Tools with Respect to Bolus Flow Measures. Dysphagia

2006 Jul 1;21(3):141-8. 40.8. Gordin E., Lee Thomas S, Ducic Yadranko, Arnaotakis, D. Facial Nerve Trauma: Evaluation and Considerations in Management. PMID25709748. 2015;1-7.9. Nam-Gyu, R, Kim, Jin. How to avoid Facial Nerve in Mastoidectomy. J Audiol Otol. 2016 Sep; 20(2): 68–72.10. Lo C, Kwok F, Yuen P. A prospective evaluation of recurrent laryngeal nerve paralysis during thyroidectomy. Archives of Surgery 2000;135(2):204-7.11. Randolph GW and Dralle H with the International Intraoperative Monitoring Study Group. Electrophysiologic recurrent laryngeal nerve monitoring during thyroid and

parathyroid surgery: international standards guideline statement. Laryngoscope 2011; 121:S1-S16.12. Dionigi G, et al. The technique of intraoperative neuromonitoring in thyroid surgery. Surg Technol Int. 2010;19:25-37.13. Thomusch O, et al. Intraoperative neuromonitoring of surgery for benign goiter. Amer J Surg. 2002;183(6):673-8.14. Wolf G, What Patients Should Know in Decision Making. Rogel Cancer Center, 2020, Jul. Accessed 9-25-2020. https://www.rogelcancercenter.org/head-and-neck-

cancer/voicebox/what-patients-should-know.15. Chiang FY, et al. Standardization of intraoperative neuromonitoring of recurrent laryngeal nerve in thyroid operation. World J Surg. 2010 Feb;34(2):223-9.16. Zoulamoglou M., Zarokosta M., Kaklamanos I., et al. Anatomic variation of the relation between the facial nerve and the retromandibular vein during superficial

parotidectomy. Int J Surg Case Rep. 2017; 41: 124–127.17. Ballivet-de Régloix, S, Grinholtz-Haddad, J et al. Facial Nerve Monitoring During Parotidectomy:A Two-Center Retrospective Study. J Otorhinolaryngol. 2016 Jul; 28(87):

255–260. 18. Tsirline VB, Lau KN, Swan RZ, et al. Evaluation of an innovative, cordless ultrasonic dissector. Surg Innov 2013; 20(5):524-29.19. Kim FJ, Sehrt D, Pompeo A, et al. Comparison of surgical plume among laparoscopic ultrasonic dissectors using a real-time digital quantitative technology. Surg Endosc

2012; 26(12):3408-12.20. Phelan E, Schneider R, Lorenz, K, et al. Continuous Vagal IONM Prevents Recurrent Laryngeal Nerve Paralysis by Revealing Initial EMG Changes of Impending Neuropraxic

Injury: A prospective, Multicenter study. The Laryngoscope 2013, 2.21. Dionigi G, et al. Safety of neural monitoring in thyroid surgery. International Journal of Surgery (2013) 11(S1), S120–S126:2.22. Based on internal study. Shiley™ Laser Flex Oral/Nasal Tracheal Tube 16-AW-0047-[WF#1224741].23. Lai HC, Juang SE, Liu TJ, et al. Fires of endotracheal tubes of three different materials during carbon dioxide laser surgery. Acta Anaesthesiol Sin 2002; 40(1):47-51.24. Alvarado CJ, Anderson AG, Maki DG. Microbiologic assessment of disposable sterile endoscopic sheaths to replace high level disinfection in reprocessing: A prospective

clinical trial with nasopharyngoscopes. Am J of Infect Control 2008; 37:408-13.25. Based on internal test report #R0042752 rev A.26. Stopa M. Prognostic value of intraoperative neural monitoring of the recurrent laryngeal nerve in thyroid surgery. Langenbecks Arch Surg.27. Ekberg O, Hamdy S, et al. Social and Psychological Burden of Dysphagia: Its Impact on Diagnosis and Treatment. Dysphagia 17:139-146 (2002).28. Data on file.29. Wilson JA, Deary IJ, Miller A, et al. The quality of life impact of dysphonia. Clin Otolaryng 2002;27:179-82.30. Brown M., Oliphant T and J. Langry. Motor nerves of the head and neck that are susceptible to damage dermatological surgery. Clinical and Experimental Dermatology

doi:10.1111/ced.12374.31. Boerner M. Etiology and management of facial palsy. Current Opinion in Ophthalmology 1994, 5;V:61-661994, 5:V:61-66.32. Bilezikian JP, Khan A, Potts JT, et al. Hypoparathyroidism in the adult: epidemiology, diagnosis, pathophysiology, target-organ involvement, treatment, and challenges for

future research. J Bone Miner Res. 2011;26:2317e2337. 33. Murphy, E, Williams G. Hypocalcaemia. Medicine, 2005; 33(12):55-57. 34. Liu, Rui Han, et al. “Association of Hypocalcemia and Magnesium Disorders With Thyroidectomy in Commercially Insured Patients.” JAMA Otolaryngology–Head. * Compared to visualization alone** Compared to NIM-Response™ 3.0 and NIM-Neuro™ 3.0

Rx only. Refer to product instruction manual/package insert for instructions, warnings, precautions and contraindications.

For further information, please call Medtronic ENT at 800-874-5797 or consult Medtronic’s website at medtronic.com/ent.

© 2020 Medtronic. All rights reserved. Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic. All other brands are trademarks of a Medtronic company. UC202109914 EN

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