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Process Study 24-Month Results

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  1. Process Study24-Month Results October 1, 2008(abridged)

  2. Study Design for Primary Endpoint(≥ 50% Reduction in Leg Pain (VAS) at 6 Months)

  3. PROCESS Study Summary of ITT Results Until 6 Months (Kumar K et al. Pain 2007) Patients in the SCS and CMM groups were: Well matched Representative of patients with FBSS, suffering from neuropathic pain predominantly in the legs Significantly better outcomes were observed in the SCS group in terms of: Pain relief (leg and back VAS) – the primary outcome 48% patients reaching ≥ 50% leg pain relief vs. 9% in CMM group 64% patients reaching ≥ 30% leg pain relief vs. 18% in CMM group Disability (Oswestry Disability Index) Quality of life (SF-36 and EQ-5D) Patient satisfaction Occurrence rate of SCS-related events comparable to literature

  4. 24-month AnalysisSCS-continue Group The 24 month analysis focuses on the SCS+CMM-continue group i.e. patients randomised to SCS who remained on SCS until 24 months The following analyses have been limited to the primary outcome only (vs. CMM): Revised ITT (where all patients requesting crossover are considered as having < 50% pain relief at 24 months) Per treatment analyses (based on the treatment the patient is receiving at the 24 months visit)

  5. Rationale For Focusing on the SCS Continue Group High and uneven crossover after 6 months 4 / 46 (9%) SCS+CMM patients with a 24m visit had crossed to CMM 30 / 41 (73%) CMM patients with a 24m visit had crossed to SCS+CMM other analyses no longer relevant

  6. Patient Flow Through 24 Months

  7. Leg Pain Relief in SCS+CMM-continue Group Over 24 Months Significant Reduction in Leg Pain VAS Over 24 Months

  8. Primary Outcome: ≥ 50% Leg Pain Relief at 24 MonthsContinued Greater Effect with SCS in the Per Treatment/ITT Analyses Over 24 Months

  9. Leg Pain Relief in SCS+CMM-continue Group at 24 Months ≥ 30% Leg Pain Relief Maintained in the Majority of Patients Over 24 Months

  10. QoL in SCS+CMM-continue Group at 24 MonthsSignificant Improvement in 7/8 Domains of QoL (SF-36) Over 24 Months

  11. Quality of Life in SCS+CMM-continue Group Over 24 MonthsSignificant Increase in QoL (EQ-5D) Over 24 Months

  12. Function in SCS+CMM-continue Group Over 24 Months Significant Improvement in Function (Oswestry Disability Index) Over 24 Months

  13. Satisfaction in SCS+CMM-continue Group Over 24 MonthsHigh Patient Satisfaction Maintained Over 24 Months “Are you satisfied with the pain relief provided by your treatment?” “Based on your experience so far, would you have agreed to this treatment?”

  14. SCS-related Complications in SCS-continue Patients: 24 Months19 (45%) Patients Had Total 34 Complications, 13 (31%) Patients Required Surgery IPG: implantable pulse generator; * 1) Case of suboptimal connection of extension to IPG, leading to intermittent stimulation; 2) Lead implanted anteriorly, leading to patient receiving shocks; 3) lead cut during implant

  15. PROCESS Study Summary of Results at 24 Months In ITT and per treatment analyses, significantly more SCS patients achieved the primary outcome of ≥ 50% leg pain relief. Significant difference from baseline achieved in the SCS-continue group in main outcomes: Leg pain relief (p < 0.0001) Quality of life (SF-36 and EQ-5D, p ≤ 0.01) Disability (ODI, p = 0.0002) No significant change in drug and non drug treatments Complications in line with the literature 45% of patients had ≥ 1 complications, 31% of patients required surgery High patient satisfaction, increasing number of patients return to work Sustained effect of SCS over 24 months

  16. Thank You to the Participating Centers! UC201002470 EN