TransDiscal TM System

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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 tearsIncreased shear stress across annular wall.

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TransDiscal TM System

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1. TransDiscal TM System For intervertebral disc biacuplasty in the management of axial low back pain

2. 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

3. 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

4. History of Treating the Disc With Heat

5. Patient Selection

6. 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.

7. Transdiscal Bipolar RF Disc Treatment

8. Initial Introducer Placement

9. Lateral View- Electrode Position

10. Anterior-Posterior View

11. Cleveland Clinic Cadaver Study

12. Cleveland Clinic Cadaver Study Near physiologic temperatures maintained in the epidural space and neural foramina. Near physiologic temperatures maintained in the epidural space and neural foramina.

13. In vivo porcine safety study In vivo animal testing and cadaver testing has verified the temperature profile established in white meat testing. Physiologic temperatures are maintained at the nerve root and the dural sac. In vivo animal testing and cadaver testing has verified the temperature profile established in white meat testing. Physiologic temperatures are maintained at the nerve root and the dural sac.

14. 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. Results Notice the rapid decline in pain scores and improvement in function In most cases almost a week later!

16. Significant declines in functional and VAS but not did not reach statistical decline in opioid use

17. Pain Management SInergy TM System For effective denervation in the treatment of SIJ Syndrome

18. SI Joint Innervation Innervation has been elucidated by anatomical study In this study authored by Dr. Way Yin, the lateral branches of several cadavers were revealed using careful dissection. Thin wires were laid over each nerve that ran into the sacroiliac joint. Fluoro images were taken to show the relationship of the nerves to landmarks such as the foramina and the joint. Innervation has been elucidated by anatomical study In this study authored by Dr. Way Yin, the lateral branches of several cadavers were revealed using careful dissection. Thin wires were laid over each nerve that ran into the sacroiliac joint. Fluoro images were taken to show the relationship of the nerves to landmarks such as the foramina and the joint.

19. 1Cohen S. Anesth Analg. 2005: 101: 1440-1453; 2Yin W. et al. Spine. 2003; 28(20):2419-2425 3Grob K. et al. Z Rheumatol. 1995;27:117-122; 4Fortin J. et al. Spine. 1994;19(13):1475-1482 5Willard F. et al. World Congress on Low Back and Pelvic Pain. Vienna, Austria, 1998 The variability of nerve location represents the fundamental challenge of treating sacroiliac joint syndrome The Yin study suggests that lateral branch nerves are likely to exit the foramen through certain ‘zones’ that correspond to hours on a clock-face. There exists no other correlation between nerve location and the bony landmarks identifiable under fluoroscopy. The variability of nerve location represents the fundamental challenge of treating sacroiliac joint syndrome The Yin study suggests that lateral branch nerves are likely to exit the foramen through certain ‘zones’ that correspond to hours on a clock-face. There exists no other correlation between nerve location and the bony landmarks identifiable under fluoroscopy.

20. 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

21. Sacroiliac RF Lesion Requirements Level L5 Lesion the primary dorsal ramus at sacral ala Level S1, S2, S3 Lesion all lateral branches as they exit foramen Treatment rational: Create large volume lesions in the ‘zones’ where the lateral branch nerves are likely to be. Problem: Standard RF lesions are too small to treat each zone in an effective and efficient manner.Treatment rational: Create large volume lesions in the ‘zones’ where the lateral branch nerves are likely to be. Problem: Standard RF lesions are too small to treat each zone in an effective and efficient manner.

22. Cooled RF Lesions Isotherm Map White meat tests comparing SInergy probe and Standard RF Solution: Cooled RF technology allows the creation of large volume, controlled, repeatable lesions. Internal cooling and a small (4mm) active tip allow for controlled and repeatable lesions. Lesion are spherical (8-10mm in diameter), and project distally to capture nerves lying along the surface of the sacrum. Distal projection allows for perpendicular placement towards the target neural structure. The lesion is 60°C at the surface of the electrode. The hottest temperature in the lesion is about 75°C This isotherm map has been confirmed through bench testing and cadaver testing. It has also been confirmed through in vivo temperature monitoring experiment (publication of data is pending). Solution: Cooled RF technology allows the creation of large volume, controlled, repeatable lesions. Internal cooling and a small (4mm) active tip allow for controlled and repeatable lesions. Lesion are spherical (8-10mm in diameter), and project distally to capture nerves lying along the surface of the sacrum. Distal projection allows for perpendicular placement towards the target neural structure. The lesion is 60°C at the surface of the electrode. The hottest temperature in the lesion is about 75°C This isotherm map has been confirmed through bench testing and cadaver testing. It has also been confirmed through in vivo temperature monitoring experiment (publication of data is pending).

23. Physics of Cooled RF Lesions Without cooling, the size of lesion is limited by the heat generated in the tissue adjacent to the electrode Cooling the tissue adjacent to the electrode allows effective heating at a greater distance Physics of Cooled RF- Cooling the electrode removes heat from the tissue immediately adjacent to the active tip. This prevents overheating (>95C, cavitation, charring) of this tissue, and allows the generator to create a higher power, and therefore larger lesion. Graph Description: Parallel lines in the center of the graph represents the electrode. Dashed lines indicate the heat profile (temperature vs. distance from electrode) for standard RF Solid lines indicate the heat profile for Cooled RF. Physics of Cooled RF- Cooling the electrode removes heat from the tissue immediately adjacent to the active tip. This prevents overheating (>95C, cavitation, charring) of this tissue, and allows the generator to create a higher power, and therefore larger lesion. Graph Description: Parallel lines in the center of the graph represents the electrode. Dashed lines indicate the heat profile (temperature vs. distance from electrode) for standard RF Solid lines indicate the heat profile for Cooled RF.

24. Perpendicular & Oblique Placement Spherical lesion shape allows for perpendicular or oblique probe placement near the treatment site. Spherical Lesions allow for perpendicular or oblique probe placement towards the targetSpherical Lesions allow for perpendicular or oblique probe placement towards the target

25. Electrode Placement Spinal needles are used to mark the PSFA Introducer and electrode are directed “down the beam” towards the target anatomy Electrode is positioned 7-10mm from the PSFA for safety Spinal needles are placed along the lateral edge of each foramen to provide a reference for electrode placement Introducer and electrode can be directed “down the beam” towards each target site For safety, the electrode should be 7-10mm from the foramen (i.e.7-10mm from the spinal needle) This image shows the electrode tip positioned inferior and lateral to the S2 foramen (4 o’clock position) PMG Settings are: Cooled Temp = 60°C, Time = 2:30, Ramp = 25s (80°C/min)Spinal needles are placed along the lateral edge of each foramen to provide a reference for electrode placement Introducer and electrode can be directed “down the beam” towards each target site For safety, the electrode should be 7-10mm from the foramen (i.e.7-10mm from the spinal needle) This image shows the electrode tip positioned inferior and lateral to the S2 foramen (4 o’clock position) PMG Settings are: Cooled Temp = 60°C, Time = 2:30, Ramp = 25s (80°C/min)

26. Effective Lateral Branch Ablation Anatomical studies provide guidance on lateral branch location Cooled RF technology allows for controlled and repeatable large volume lesions This allows for the effective ablation of lateral branch nerves in the treatment of sacroiliac joint syndrome Equation for success: Knowledge of anatomy + properly targeted large volume lesions = effective ablation of lateral branchesEquation for success: Knowledge of anatomy + properly targeted large volume lesions = effective ablation of lateral branches

27. SInergyTM System Clinical Outcomes Prospective Cohort Study by Dr. Robert Wright (n = 15, baseline VAS = 7) >50 % reduction in VAS considered success Pending Publication; LA = Long Acting Opioid SA = Short Acting OpioidPending Publication; LA = Long Acting Opioid SA = Short Acting Opioid

28. SInergyTM System Clinical Outcomes Placebo Controlled Study by Dr. Steven Cohen 28 patients randomized to RF or sham denervation of L4-S3 Strict success criteria: >50% VAS reduction AND Positive GPE (Global Perceived Effect) AND >10 point ODI improvement 6 month follow-up complete with strong results. Data Release Pending publication in 2007 Pending PublicationPending Publication

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