2. Lumbar Spinal Stenosis – Symptoms and Treatment Slide presentation will automatically advance to the next page every 12 seconds. If you wish to move ahead to the next slide, press the PageDown key on your keyboard. If you wish to return to the previous slide, press the PageUp key on your keyboard. Or, use next and previous buttons (appearing as double arrows) located at the bottom of the right vertical scroll bar.

3. Lumbar Spinal Stenosis: Symptoms and Treatment

4. Francis J. Pizzi, M.D., FACS, MBA Diplomate of the American Board Neurological Surgery Lumbar Spinal Stenosis: Symptoms and Treatment

6. Specialty Differences Orthopedic Surgeon Orthopedic Surgeon –15% Spine –85% Other Bones –Focus: Bones, Muscles, Joints Neurological Surgeon Neurological Surgeon –85% Spine –15% Brain and Nerves –Focus: Nerves

7. Lumbar Spinal Stenosis Not too much Magic! Too much pain after working all day to enjoy leisure time Pay the price for what you do Limited “Golden Year” activities

8. What is Lumbar Stenosis? Do I have Lumbar Stenosis? What can I do about it? –Non-Operative & Surgical Treatment –A New Alternative GOALS

9. 8 - 11% Incidence of LSS in the U.S. 8 - 11% Incidence of LSS in the U.S. 30,000,000 People!! LSS is the most common reason for spine surgery in older people LSS is the most common reason for spine surgery in older people More than 125,000 laminectomy procedures are performed annually for LSS More than 125,000 laminectomy procedures are performed annually for LSS Financial impact and lost work hours reaches billions of dollars each year in the U.S. Financial impact and lost work hours reaches billions of dollars each year in the U.S. Lumbar Spinal Stenosis (LSS)

10. Anatomy of the Spine

11. Understanding your spine: Helpful Terms Spinous Process Interspinous space Vertebra Disc Lumbar Spine (L1-L5) Anatomy of the Spine

12. Lumbar Spine

13. Extension – occurs when standing Flexion – Occurs when sitting or bending forward Anatomy of the Spine Understanding your spine: Helpful Terms

14. Stenotic Vertebrae provide body support Discs act as “shock absorbers” Vertebra protects spinal cord and nerves Nerves have space and are not pinched As we age, ligaments and bone can thicken Narrowing is called “stenosis” Narrowing squeezes nerves in spinal canal and nerve roots exiting spine to legs Result - pain & numbness in back and legs Nerve Root Spinal Canal Lumbar Vertebra Bone (Facet Joint) Healthy Intervertebral Disc Thickened Ligament Flavum Pinched Nerve Root Narrowed Spinal Canal

15. Spinal Pain Axial Pain – Back Pain –From bones, joints, muscles, discs Neurogenic Pain – Leg Pain +/- Tingles –From nerve irritation

16. Sitting or bending forward relieves symptoms Standing provokes symptoms Pain/weakness in the legs Patients lean forward while walking to relieve symptoms Symptoms of Lumbar Spinal Stenosis (Elevator Syndrome)

17. Classic Presentation: Dull or aching back pain spreading to your legs Numbness and “pins and needles” in your legs, calves or buttocks Weakness, or a loss of balance A decreased endurance for physical activities Symptoms of Lumbar Spinal Stenosis

18. Pay the price for physical activity – 24 Hours Lack of activity may lead to: Obesity Hermitism Depression What is so golden about the “Golden Years”? Lumbar Spinal Stenosis Carries a Burden!

19. Treatment Options

20. Non-operative care Avoid activities that bring on pain (24 Hour Thermostat) –Impact aerobics –Frequent bending, twisting, lifting Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), Herbals Physical Therapy, Chiropractic, Exercise & Weight Reduction –To help stabilize the spine –Lessen the burden on the spine –Reduce irritation of pain sensitive structures Lumbar Spinal Stenosis Treatment Standard of Care: Mild to Moderate Symptoms

21. Epidural Steroid Injection –Reduce swelling and inflammation of nerves –May or may not be effective (24-48 Hours) –Can break a pain cycle but will not correct underlying problem –Typically limited to 3-4 injections every 12 months

22. Lumbar Spinal Stenosis Treatment Standard of Care: More Severe Symptoms Laminectomy Un-roofing the spine, Opening the “pipe” Removal of parts of the vertebra, including: –Lamina (bone) –Attached ligaments –Facets (bone) Goal: relieve pressure on nerves by increasing size of spinal canal and nerve exit openings Most common surgery for stenosis, may require a fusion General anesthesia In-patient procedure 6-12 week recovery.

23. Lumbar Spinal Stenosis Treatment Options Surgical Care Laminectomy Laminectomy with Fusion Non Operative Care Lifestyle modification NSAIDs & other drugs Exercise & weight reduction PT, Chiropractic Epidural injections Spinal Stenosis Symptoms: Continuum of Care MildSevereModerate Atlas - Clin Orth Rel Res 2006.

24. Surgical Care Laminectomy Laminectomy with Fusion Non Operative Care Lifestyle modification NSAIDs & other drugs PT, Chiropractic Epidural injections X-STOP ® Spacer Spinal Stenosis Symptoms: Continuum of Care MildSevereModerate Lumbar Spinal Stenosis Treatment Options.

25. The X-STOP ® Spacer X-STOP Spacer is implanted, separating the spinous processes and relieving pinched nerves Designed to remain safely and permanently in place The first Interspinous Spacer approved by FDA to treat the symptoms of LSS Pre-Op Post-Op “Kissing” Spinous Processes

26. The X-STOP ® Spacer Minimally invasive procedure Rapidly alleviates pain Typically doesn’t require the removal of bone or tissue Can be done under local anesthesia Low rate of complications Not attached to bone or ligaments

27. The X-STOP ® Spacer Supraspinous ligament Spinous process Spacer only limits extension Wings prevent side-to-side and upward migration Preserves your supraspinous ligament, which prevents backward migration Preserves anatomy Treats LSS symptoms, not “anatomy”

28. X-STOP ® Superior to Non-operative Care Differences between X-STOP and Control groups statistically significant (p < 0.001) at all follow-up intervals. (all 3 criteria) SOURCE: X-STOP ® IPD ® System Summary of Safety and Effectiveness (SSE); Includes all study sites.

29. Compared to traditional LSS surgery, X-STOP benefits include: Can be done under local anesthesia Can be done as an outpatient procedure No removal of the lamina (vertebral bone) or ligaments that protect and stabilize the spine Potential of a shorter recovery The X-STOP Spacer

30. Are you a candidate? The X-STOP Spacer is indicated for: People aged 50 or older Pain or weakness in the legs Confirmed diagnosis of lumbar spinal stenosis Moderately impaired physical function Experience symptom relief in flexion (sitting) Completed 6 months of non-operative treatment Operative treatment indicated at one or two lumbar levels (but no more than 2 levels)

31. X-STOP ® IPD ® System Instructions For Use (IFU) Contraindications The X STOP is contraindicated in patients with: an allergy to titanium or titanium alloy; spinal anatomy or disease that would prevent implantation of the device or cause the device to be unstable in situ, such as: –significant instability of the lumbar spine, e.g., isthmic spondylolisthesis or degenerative spondylolisthesis greater than grade 1.0 (on a scale of 1 to 4); –an ankylosed segment at the affected level(s); –acute fracture of the spinous process or pars interarticularis –significant scoliosis (Cobb angle greater than 25 degrees); cauda equina syndrome defined as neural compression causing neurogenic bowel or bladder dysfunction; diagnosis of severe osteoporosis, defined as bone mineral density (from DEXA scan or some comparable study) in the spine or hip that is more than 2.5 SD below the mean of adult normals in the presence of one or more fragility fractures; active systemic infection or infection localized to the site of implantation.

32. X-STOP® Interspinous Process Decompression (IPD®) System 16000805 Rev 1

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