CAUTION: The Spinal Modulation Axium™ Spinal Cord Stimulator System is an investigational device...
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CAUTION: The Spinal Modulation Axium™ Spinal Cord Stimulator System is an investigational device and is limited by United States law to investigational
CAUTION: The Spinal Modulation Axium Spinal Cord Stimulator
System is an investigational device and is limited by United States
law to investigational use only. Effects of Spinal Cord Stimulation
of the Dorsal Root Ganglion (DRG) in the Treatment of Chronic,
Intractable Pain: Long-Term Results from Two Prospective Clinical
Trials L Liem, M.D. F Huygen, M.D., Ph.D Marc Russo, M.D. JP Van
Buyten, M.D. I Smet, M.D. Paul Verrills, M.D. Professor Michael
Cousins, M.D. Raj Sundaraj, M.D. Charles Brooker, M.D. NANS
2012
Slide 2
CAUTION: The Spinal Modulation Axium Spinal Cord Stimulator
System is an investigational device and is limited by United States
law to investigational use only. Disclosures Philips Boston
Scientific Spinal Modulation Caution: The Spinal Modulation Axium
Spinal Cord Stimulator System is currently an investigational
device in the United States and is not approved for use in the
United States.
Slide 3
CAUTION: The Spinal Modulation Axium Spinal Cord Stimulator
System is an investigational device and is limited by United States
law to investigational use only. Specialized delivery system for
efficient access to the foramen Small, flexible leads have been
designed specifically for stimulation of the DRG Small, non-
rechargeable neurostimulator designed to complement the lead and
system Conventional Lead DRG Lead Spinal Cord Stimulation Targeting
the Dorsal Root Ganglion
Slide 4
CAUTION: The Spinal Modulation Axium Spinal Cord Stimulator
System is an investigational device and is limited by United States
law to investigational use only. Clinical Study Design 2
prospective clinical trials Sites in Europe and Australia enrolled
subjects N=32 subjects implanted with Spinal Modulation Axium
Spinal Cord Stimulator System Primary and secondary outcome
measures captured Two (2) on-off periods to demonstrate rebound
pain 3-30 days Stimulation turned off Trial 1 week Screen Fail
Baseline 4 weeks 1 year Baseline Implant Trial Exit 1 week off 1
week off yes no 6 months 3 months 8 weeks* Stimulation turned off
Success?
Slide 5
CAUTION: The Spinal Modulation Axium Spinal Cord Stimulator
System is an investigational device and is limited by United States
law to investigational use only. Study Outcomes Primary Efficacy
was determined by Visual Analog Scale (VAS) Both overall pain and
regional (segmented) VAS scores were collected over time based upon
primary, secondary and/or tertiary areas of pain Safety was
evaluated by collecting adverse events during the course of the
trial Secondary Health Related Quality of Life (HR-QoL) EQ-5D
Profile of Mood States (POMS) Brief Pain Inventory (BPI) Subject
Satisfaction Paresthesia Intensity with Changes in Bodily
Position
Slide 6
CAUTION: The Spinal Modulation Axium Spinal Cord Stimulator
System is an investigational device and is limited by United States
law to investigational use only. Subject Diagnoses Diagnosis#INS
FBSS9 CRPS8 Post-surgical neuropathic pain conditions7 Radicular
pain8 Total Implants32
Slide 7
CAUTION: The Spinal Modulation Axium Spinal Cord Stimulator
System is an investigational device and is limited by United States
law to investigational use only. PRIMARY OUTCOMES Visual Analog
Scores (VAS)
Slide 8
CAUTION: The Spinal Modulation Axium Spinal Cord Stimulator
System is an investigational device and is limited by United States
law to investigational use only. Primary Outcomes Overall Pain
Relief 60% reduction at 12 months VAS (mm) n=32 n=30n=24 n=17
Slide 9
CAUTION: The Spinal Modulation Axium Spinal Cord Stimulator
System is an investigational device and is limited by United States
law to investigational use only. 66% reduction at 12 months *
Diagnoses include CRPS, Post-Surgical Pain, FBSS, Radicular Pain
Primary Outcomes Leg Pain* VAS (mm) n=25 n=24n=19n=22n=19n=13
Slide 10
CAUTION: The Spinal Modulation Axium Spinal Cord Stimulator
System is an investigational device and is limited by United States
law to investigational use only. 82% reduction at 12 months *
Diagnoses include CRPS, Post-Surgical Pain, FBSS Primary Outcomes
Foot Pain* VAS (mm) n=13 n=9n=12n=10n=6
Slide 11
CAUTION: The Spinal Modulation Axium Spinal Cord Stimulator
System is an investigational device and is limited by United States
law to investigational use only. 1 week No Stim 1 week No Stim
Assessing Rebound Pain after Stimulation is Turned Off
Slide 12
CAUTION: The Spinal Modulation Axium Spinal Cord Stimulator
System is an investigational device and is limited by United States
law to investigational use only. Less Lead Migration than
traditional SCS Stimulation leads for SCS of the DRG reported