human spinal cord modulation system (hscms) designed to address major unmet public heath need...
TRANSCRIPT
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Human Spinal Cord Modulation System (HSCMS) Pre IDE Meeting
January 17th, 2013
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Attendees • Matthew Howard, III, MD –
Professor and Head, Department of Neurosurgery, University of Iowa
• Timothy Brennan MD,PhD – Professor and Vice Chairman, Department of Anesthesiology, University of Iowa
• George T. Gillies, PhD – Research Professor, Department of Mechanical and Aerospace Engineering, University of Virginia
• Randy Nelson – Founder and President, Evergreen Medical Technologies
• Daniel O’Connell MBA – NeuroVentures Inc.
• Roy Martin ,DVM- Chief Medical Officer, NAMSA – Integra Division
• Noelle Sutton – Principal Regulatory Consultant, NAMSA
• Jennifer Mischke, MPH –Director of Biostatistics, NAMSA
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Spinal Cord Stimulation (SCS) History
1960’s - advent of human SCS treatment
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Spinal Cord Stimulation (SCS) History
• Initially intra-dural and extra-dural device placement
• Intra-dural devices abandoned – Tethering between the spinal cord and dura – Increased risk of cerebrospinal fluid (CSF) leak – Poor control of electrode location relative to targeted sub-region of
the spinal cord
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Extra-Dural Spinal Cord Stimulators (all current devices)
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Key Anatomical Considerations
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Extra-Dural Stimulation Patterns
Derived from: • Holsheimer J. Spinal Cord 36:531-540, 1998. • Holsheimer J. Neuromodulation 5:25-31, 2002 • Holsheimer J, et al . Neuromodulation 10: 34-41, 2007
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Functional Access to Spinal Cord Pathways
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Functional Access to Spinal Cord Pathways Using Current SCS Devices
< 1 %
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Poor Activation Pattern = Suboptimal Results
Percentage of patients reporting > 50% pain relief
- 38 % (Taylor RS et al. Spine 30:152-160, 2004)
- 53 % (North RB et al. Spine 30:1412-1418, 2005)
- 48 % (Kumar KA et al. Pain 132:179-188, 2007)
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Spinal Cord Pathway Access Current SCS vs. HSCMS
(* including penetrating electrode variants)
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Direct Spinal Cord Stimulation
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HSCMS?
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Background Information • HSCMS is a thin, soft electrode-bearing array placed directly
on the dorsal surface of the spinal cord. • Designed to address major unmet public heath need
(medically refractory neuropathic pain affecting the back and legs).
• The HSCMS addresses a fundamental limitation of all existing
human spinal cord modulation devices: an inability to deliver effective treatment, safely to a large population of chronic patients by selectively targeting locations within the human spinal cord parenchyma.
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Background Information Computational Results from Early
Attempts at Finite Element Modeling Human Spinal Cord Neural Pathways
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Background Info
HSCMS markedly increases the number of axons that are stimulated, resulting in a greater therapeutic effect
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Device Description
• The HSCMS is a thin, soft electrode-bearing array that is placed directly on the dorsal surface of the spinal cord.
• The HSCMS is designed to position electrodes directly on the
surface of the spinal cord, and in the future within the parenchyma of the spinal cord, thus allowing safe and effective access to all regions of the spinal cord.
• The electrode-bearing portion of the device is gently held in
place by flexible lead segments.
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Device Components
• Electrode bearing portion
• ‘Inside loop’ malleable lead segments
• Attachment arms • Dural cuff • Titanium strap • Stimulus delivery unit
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GLP Study Design Enrollment
N=12 Healthy
CBC/profile Neuro exam
Daily Observations Adverse Events
Implantation Procedure CRF
Implant Radiology Baseline electrical performance
2-week recovery
1-month Follow-up N=6
3-month follow-up N=6
Daily Observations Adverse Events
Weekly neurologic exams Monthly impedance checks
Terminal Fluoroscopy Sacrifice Necropsy Histology
Safety Effects of implantation
Tox
Necropsy Implant histology
Tox histology
Terminal Fluoroscopy
Sacrifice Necropsy Histology
Safety Effects of implantation
Tox
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HSCMS Pilot Clinical Study Design 2 sites
12 patients 6-month endpoint outcomes assessment
Primary Objective • To describe the safety and efficacy of HSCMS in patients that have received
conventional treatments and have inadequate pain relief.
Design • Prospective, single arm • Screening, implant, 2 Week, Month 1, Month 3 and Month 6 visits
Endpoints • Primary Safety: All serious, device related adverse events
• Primary Efficacy: Visual analog scale (VAS) for back pain and VAS for leg pain
• Secondary endpoints: Quality of life assessments and work status
• Additional endpoints: All adverse events (type, relationship, severity, seriousness)