1. Spinal Cord Stimulation (SCS): A proven surgical option for chronic pain
Jeffrey M. Epstein, M.D.
Babylon, NY

2. Disclosure See This presentation is for educational purposes only.
Boston Scientific does not make any representation
about the accuracy of the statements made by the
physician.
Dr. Epstein is a paid consultant of Boston Scientific Neuromodulation Corporation.

3. Spinal Cord Stimulation
What is SCS?
Sends electrical signals to the spinal cord to control chronic pain
Safe & effective therapy
Common Indications
Low Back Pain
Post Laminectomy Pain
Leg Pain

4. SCS: An Alternative to Reoperation
3X’s Greater Success Rate than Reoperation for post laminectomy pain
47% of SCS patients were satisfied with treatment as compared to 12% for reoperation patients (p<0.01, n=45).
North et al, Spinal Cord Stimulation Versus Repeated Lumbrosacral Spine Surgery for Chronic Pain: A Randomized, Controlled Trial, Neurosurgery 2005;56:

5. SCS Technology Advancements
See
CoverEdge 32
CoverEdge X 32
32 Contact Surgical Leads

6. LUMINA Surgical Study Multi-center, consecutive observational study
Study Design
Multi-center, consecutive observational study
Sample Size
100 implanted subjects [47 subjects with axial back pain ONLY – no radicular component]
Number of Sites
6 sites
Follow-up Duration
24 months (currently at 12 months post-implant)
Key Inclusion
Criteria
Real-world cohort – only requirement is on label treatment

7. LUMINA 32 Surgical Lead Group
See
Δ (12 mos) = 5.1
p<0.001
Δ (12 mos) = 6.1
p<0.001
2.8
Pilitsis et al., AANS Note: Clinical study results may not necessarily be indicative of clinical performance. Results in other studies may vary

8. LUMINA 32 Surgical Lead Group
See
Δ (12 mos) = 5.1
p<0.001
Δ (12 mos) = 6.1
p<0.001
Δ = 6.1
Highly significant pain relief sustained out to 1 Year post-implant.
Average NRS below 3 at 1 year
Δ = 6.1 (Exclusive Axial Back Pain – No radicular component)
Frey et al., NANS Note: Clinical study results may not necessarily be indicative of clinical performance. Results in other studies may vary

9. Reduction in Disability (Frey et. al.)
Frey et al., WIP Note: Clinical study results may not necessarily be indicative of clinical performance. Results in other studies may vary

10. Patient Access to Care
Covered by most insurance plans, including Medicare and most worker’s compensation programs*
SCS reimbursement may be commensurate with some of the most commonly performed spine procedures
* Boston Scientific recommends that you consult with your payers, reimbursement specialists and/or legal counsel regarding coding, coverage and reimbursement matters.

11. Integrating SCS into Your Practice
Long-term care commonly managed by pain physician
Partnership with pain management
Common surgical procedure
Images Provided by Boston Scientific

12. Summary SCS is a proven surgical option for chronic pain
Commonly used for post laminectomy pain and leg pain
New technology makes SCS an option for low-back pain
Reimbursement facilitates patient access to care
SCS fits well into any surgical practice

13. Indications for Use US Indications for Use:
The Boston Scientific Neuromodulation Spinal Cord Stimulator (SCS) Systems are indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back pain, and leg pain.
Contraindications, warnings, precautions, side effects. The SCS Systems are contraindicated for patients who: are unable to operate the SCS System, have failed trial stimulation by failing to receive effective pain relief, are poor surgical risks, or are pregnant. Refer to the Instructions for Use provided with the SCS System or ControlYourPain.com for potential adverse effects, warnings, and precautions prior to using this product.
WHISPER and ACCELERATE- Caution: Investigational Device. Limited by US law to investigational use only. Not available for sale.
Caution: Federal (U.S.) law restricts this device to sale by or on the order of a physician.
Outside of US Indications for Use:
For further information refer to the product labeling and Instructions for Use provided with each product which includes indications, contraindications, warnings and precautions.
Results from clinical studies are not predictive of results in other studies. Results in other studies may vary.
The Precision Spectra SCS System with ImageReady MRI Technology is “MR-Conditional” only when exposed to the MRI environment under the specific conditions defined in the ImageReady™ MRI Guidelines for Precision Spectra™ Spinal Cord Stimulator System.
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