mild? Decompression for the Treatment of Lumbar Spinal Stenosis

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mild? Decompression for the Treatment of Lumbar
Spinal Stenosis
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Disclosure

• I am an inventor of the mild? procedure and
  instruments an investor in Vertos Medical Inc.

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Purpose
To evaluate the safety and efficacy of minimally
invasive lumbar decompression, the mild?
procedure, for the treatment of lumbar spinal
stenosis.
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Lumbar Spinal Stenosis

• 1.4 M people diagnosed with LSS each yearin the
  USA growing due to aging boomers
• Present in 10 of all adults gt than 65 years old
• One of the most common indications for surgical
  intervention in patients over 55 years old
• Limited therapeutic options short of open surgery
• Patients with moderate to severe symptoms show
  clear benefit with surgical decompression over
  conservative (non-interventional) treatment

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Severe Spinal Stenosis

• Thecal sac significantly compressed
• Area 85 mm2
• AP 6-8 mm
• Ligament 4 mm
• Usually symptomatic

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The Procedure mild?

• Minimally Invasive Lumbar Decompression
• A new percutaneous procedure that addressesa
  root cause of patients symptoms
• Decompress bone ligament to widen the canal
  thereby relieve claudication symptoms
• FDA approved instruments for laminotomy
  decompression and
• Delays or prevents need for further intervention
• Covered under existing DRG codes

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mild? Instruments
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Debulk Collagenous Tissue
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Procedural Steps
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Patient DW

• 85 year old male with mixed etiology back and leg
  pain with signficant neurogenic claudication
• Not a surgical candidate for medical reasons
• Procedure done under local with total of 200?
  Fentanyl and 4mg of Versed
• Patient discharged next morning (lt24 hour
  hospitalization)

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Epiduragram
L3
L3
L4
L4
Spill over to L4/5 level
L5
L5
12/17/07
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Placement of Trocar
AP
Oblique Laterial
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Laminotomy
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Tissue Excision
Rotation of device 90
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Cavitygram
cavitygram
advancing the catheter
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Outcome

• No procedural complications
• At three weeks post procedure, patient relates
  that his claudication symptoms have improved
• He was able to extend at waist without pain,
  which he couldnt do before

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Materials and Methods

• A meta-analysis of 9 IRB approved clinical
  patient series from multiple institutions in the
  USA and Canada evaluated gt 270 patients for
  safety
• 3-Mo clinical efficacy of the mild? procedure
  evaluated in 107 patients
• Clinical efficacy was evaluated with a battery of
  PRO instruments including the VAS, the ODI
• Outcomes and procedure safety were compared to
  the SPORT trial. NEJM 2008358794-810
• Clinical follow-up ranged from six weeks to one
  year for these series.

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Results
Denotes 3 point responders only (7/10
patients) All data is on file at Vertos
Medical and verified by the clinician
researchers NEJM 2008358794-810 Pain
Physician 2010 1335-41
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Results

• Of the series evaluated
• Acute data is available for 324 patients (253
  from the meta analysis)
• 163 patients are currently followed for pain and
  disability
• 3 month follow-up data is available for 107
  patients
• Patients experienced a statistically significant
  (plt 0.0001, t-test for correlated samples)
  three-month follow-up pain disability score
  improvement from baseline

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Demographics

• Of 253 patients from the meta-analysis
• Mean age 69.0
• 39.1 male
• 60.9 female

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Results
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Results
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Results
Efficacy mild SPORT
Surgical Cohort

Patients 107 394

Pain VAS LEBS
Baseline 7.4 4.1
3 Mo Follow-up 3.9 2.1
Improvement (3.5) 47.3 (2.0) 48.8
Baseline 3 Mo Follow-up Improvement BPBS 4.3 1.6 (2.7) 62.8
ODI (17.10) (21.40)
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Conclusions

• No serious adverse events (SAEs) have been
  recorded with the mild? procedure
• All outcome metrics demonstrated statistically
  significant symptomatic improvement over baseline
  
• Initial results compare favorably to open surgery
  despite slightly higher baseline ODI than the
  open surgery trial (SPORT) and a much lower
  complication rate