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  • 1. Copyright Baylis Medical Company 2007. The BMC logo, SInergy, and DataStream are Trademarks or Registered Trademarks of Baylis Medical Company Inc. Patents pending and/or issued. 11 TransDiscal TM System For intervertebral disc biacuplasty in the management of axial low back pain

2. Copyright Baylis Medical Company 2007. The BMC logo, SInergy, and DataStream are Trademarks or Registered Trademarks of Baylis Medical Company Inc. Patents pending and/or issued. 22 Mechanisms of Discogenic Pain Irritation of nerve endings in outer third of the annulus (Bogduk J Anat 1981) Mechanoreceptors are present in outer posterolateral portion of the lumbar disc Sensitization of nociceptors in chronic discogenic pain. (Burke JBJS 2002) In-growth of granulation tissue and small unmyelinated nerve fibers are present in degenerative disc. (Freemont AJ Lancet 1997) Nerve root irritation in full thickness tears Increased shear stress across annular wall Coppes MH et al. Spine 22:2342-50,1997, Roberts S et al. Spine 20:2645-51,1995 Kitano T et al. Clin Orthop 293, 372-377,1993, Bogduk N et al. J Anat 132:39-56,1981 Groen et al. Am J Anat 188:282-296,1990 3. Copyright Baylis Medical Company 2007. The BMC logo, SInergy, and DataStream are Trademarks or Registered Trademarks of Baylis Medical Company Inc. Patents pending and/or issued. 33 Potential Mechanisms of Pain Relief by Heating Heating nerve tissue at 45 degrees Centigrade causes irreversible neural blockade Change the structure of the collagen fibers in the annulus, causing an increase in annular stability Smith H.P., McWhorter J.M., Challa V.R., "Radiofrequency Neurolysis in a Clinical Model, Journal of Neurosurgery, Aug 1981, Vol. 55 pp.248-253 Shah RV, Lutz GE, Lee J, Doty SB, Rodeo S. Intradiskal electrothermal therapy: a preliminary histologic study. Arch.Phys.Med.Rehabil. 2001;; 82:1230-1237.82:1230-1237. 4. Copyright Baylis Medical Company 2007. The BMC logo, SInergy, and DataStream are Trademarks or Registered Trademarks of Baylis Medical Company Inc. Patents pending and/or issued. 44 History of Treating the Disc With Heat Intradiscal RF Sluijter, 1994 IDET Smith and Nephew, 1998 DiscTRODE Tyco / Radionics, 2000 5. Copyright Baylis Medical Company 2007. The BMC logo, SInergy, and DataStream are Trademarks or Registered Trademarks of Baylis Medical Company Inc. Patents pending and/or issued. 55 Patient Selection Indications Internal disc disruption Chronic pain (>6 mo) Failed conservative treatment Axial low back pain greater than referred leg pain Positive discography in 1 or 2 discs. Abnormal disc morphology Contraindications Large decrease in disc height >50% Extruded or sequestered herniation Severe degeneration Segmental instability Neurological deficit Pregnancy Endplate damage or Schmorls nodes Systemic infection or at site of treatement > 2 discs degenerated on MRI* Kapural L, Mekhail N, Korunda Z, Basali A. Intradiscal thermal annuloplasty for the treatment of lumbar discogenic pain in patients with multilevel degenerative disc disease. Anesth Analg. 99(2):472-6,2004. 6. Copyright Baylis Medical Company 2007. The BMC logo, SInergy, and DataStream are Trademarks or Registered Trademarks of Baylis Medical Company Inc. Patents pending and/or issued. 66 Transdiscal Bipolar RF Disc Treatment Radiofrequency current is concentrated between electrodes on two straight probes. The electrodes are internally cooled allowing deep, even heating and eliminating tissue adherence. Temperature sensors allow monitoring at the electrode tips and disc periphery. Heating parameters can be adjusted to achieve a specific thermal dose. cooled Tip Temperature Peripheral Temperature 7. Copyright Baylis Medical Company 2007. The BMC logo, SInergy, and DataStream are Trademarks or Registered Trademarks of Baylis Medical Company Inc. Patents pending and/or issued. 77 Transdiscal Bipolar RF Disc Treatment Heating Profile The ideal temperature profile is 55C in the inner posterior disc decreasing to 45C in the peripheral edge of the posterior disc. Temperature vs Distance Therapeutic Zone Probe Probe 35 40 45 50 55 30 8. Copyright Baylis Medical Company 2007. The BMC logo, SInergy, and DataStream are Trademarks or Registered Trademarks of Baylis Medical Company Inc. Patents pending and/or issued. 88 Initial Introducer Placement 9. Copyright Baylis Medical Company 2007. The BMC logo, SInergy, and DataStream are Trademarks or Registered Trademarks of Baylis Medical Company Inc. Patents pending and/or issued. 99 Lateral View- Electrode Position 10. Copyright Baylis Medical Company 2007. The BMC logo, SInergy, and DataStream are Trademarks or Registered Trademarks of Baylis Medical Company Inc. Patents pending and/or issued. 1010 Anterior-Posterior View 11. Copyright Baylis Medical Company 2007. The BMC logo, SInergy, and DataStream are Trademarks or Registered Trademarks of Baylis Medical Company Inc. Patents pending and/or issued. 1111 Cleveland Clinic Cadaver Study 12. Copyright Baylis Medical Company 2007. The BMC logo, SInergy, and DataStream are Trademarks or Registered Trademarks of Baylis Medical Company Inc. Patents pending and/or issued. 1212 Cleveland Clinic Cadaver Study Disc Array Disc 1 Disc 2 Disc 3 NF Array NF 1 NF 2 NF 3 Epidural Array Epidural 1 Epidural 2 Epidural 3 Epidural 4 13. Copyright Baylis Medical Company 2007. The BMC logo, SInergy, and DataStream are Trademarks or Registered Trademarks of Baylis Medical Company Inc. Patents pending and/or issued. 1313 In vivo porcine safety study Temperatures monitoring at designated safety zones outside the disc demonstrated maintenance of near-physiologic conditions while temperature across the posterior annuls reached 65C1 1 Petersohn J et al. Pain Medicine; 2007: (In Press) 14. Copyright Baylis Medical Company 2007. The BMC logo, SInergy, and DataStream are Trademarks or Registered Trademarks of Baylis Medical Company Inc. Patents pending and/or issued. 1414 Cleveland Clinic Pilot Study Primary Investigator: Dr. Leo Kapural Consent and approval by IRB-15 patients Previously denied IDET MRI and discography within 12 months Two patients out of the study, 13 followed 15. Copyright Baylis Medical Company 2007. The BMC logo, SInergy, and DataStream are Trademarks or Registered Trademarks of Baylis Medical Company Inc. Patents pending and/or issued. 1515 Results Notice the rapid decline in pain scores and improvement in function In most cases almost a week later! 0 1 3 6 51015202530 Oswestry Time (Months) OswestryScore 0 1 3 6 2030405060708090 SF-36 Physical Functionality Time (Months) SF-36PFScore 0 1 3 6 20406080 SF-36 Bodily Pain Time (Months) SF-36BPScore 0 1 3 6 0246810 VAS Pain Time (Months) VASPainScore 0 1 3 6 050100150 Opioid Use Time (Months) OpioidUse 16. Copyright Baylis Medical Company 2007. The BMC logo, SInergy, and DataStream are Trademarks or Registered Trademarks of Baylis Medical Company Inc. Patents pending and/or issued. 1616 Significant declines in functional and VAS but not did not reach statistical decline in opioid use 25th Median 75th Baseline 23.3 7.0 17 25 29 1 16.5 6.8 11 15 20 3 16.9 7.1 13 16 22 6 17.1 8.1 13 18 24 Baseline 50.8 17.5 40 55 60 1 59.4 13.0 50 55 67 3 65.7 14.4 50 70 75 6 69.9 16.2 55 70 80 Baseline 37.5 15.0 33 35 45 1 49.7 19.3 33 45 65 3 51.2 16.8 45 45 58 6 53.8 22.7 45 58 68 Baseline 7.2 1.9 6 7 8 1 3.3 2.1 2 4 5 3 3.8 1.9 3 4 5 6 3.4 1.9 2 3 5 Baseline 73.5 59.7 40 40 120 1 56.5 62.6 0 40 80 3 45.0 59.2 0 40 40 6 38.8 61.6 0 5 40 VAS Pain Score Opioid Use Quantiles Oswestry Score SF-36 PF Score SF-36 BP Score Response Variable Time (months) Mean Standard Deviation 17. Copyright Baylis Medical Company 2007. The BMC logo, SInergy, and DataStream are Trademarks or Registered Trademarks of Baylis Medical Company Inc. Patents pending and/or issued. 1717 Pain Management SInergy TM System For effective denervation in the treatment of SIJ Syndrome 18. Copyright Baylis Medical Company 2007. The BMC logo, SInergy, and DataStream are Trademarks or Registered Trademarks of Baylis Medical Company Inc. Patents pending and/or issued. 1818 SI Joint Innervation Yin W, Willard F, Carreiro J, Dreyfuss P (2003) Spine 28:2419-2425. Images reprinted with permission of Lippincott Williams, 2007. S1 S3S2 19. Copyright Baylis Medical Company 2007. The BMC logo, SInergy, and DataStream are Trademarks or Registered Trademarks of Baylis Medical Company Inc. Patents pending and/or issued. 1919 Joint is predominantly, innervated by posterior primary rami1,3,4 Nerve location is variable: 2,5 Person to Person Side to Side Level to Level Nerves may run along bone, or up to 8 mm superficial from the sacrum 5 SI Joint Innervation Yin W, Willard F, Carreiro J, Dreyfuss P (2003) Spine 28:2419-2425. Images reprinted with permission of Lippincott Williams, 2007. 1 Cohen S. Anesth Analg. 2005: 101: 1440-1453; 2 Yin W. et al. Spine. 2003; 28(20):2419-2425 3 Grob K. et al. Z Rheumatol. 1995;27:117-122; 4 Fortin J. et al. Spine. 1994;19(13):1475-1482 5 Willard F. et al. World Congress on Low Back and Pelvic Pain. Vienna, Austria, 1998 20. Copyright Baylis Medical Company 2007. The BMC logo, SInergy, and DataStream are Trademarks or Registered Trademarks of Baylis Medical Company Inc. Patents pending and/or issued. 2020 Diagnosis Referral Zones Screening Exam: Best PPV (60%)10, 11 Maximum pain below L5 coupled with pointing to the PSIS or local tenderness just medial to the PSIS has the Distraction Tests limited utility Imaging: Little value Intra articular blocks gold standard? There is a 37-66% occurrence of False positive responses from the first injection (22% FP rate)6,12 Fortin. Spine 1994; 19:1475-1482 Sacral Sulcus Tenderness Buttocks 94% Lower lumbar 72% LE 50% Groin 14% Slipman C 1998 10 Dreyfuss P, Spine 1996; 21:2594-2602, 11 Slipman C, Arch Phys Med Rehabil, 1998; 79:288-92 6 M