Title: mild? Decompression for the Treatment of Lumbar Spinal Stenosis
1mild? Decompression for the Treatment of Lumbar
Spinal Stenosis
2Disclosure
- I am an inventor of the mild? procedure and
instruments an investor in Vertos Medical Inc.
3Purpose
To evaluate the safety and efficacy of minimally
invasive lumbar decompression, the mild?
procedure, for the treatment of lumbar spinal
stenosis.
4Lumbar 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
5Severe Spinal Stenosis
- Thecal sac significantly compressed
- Area 85 mm2
- AP 6-8 mm
- Ligament 4 mm
- Usually symptomatic
6The 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
7mild? Instruments
8Debulk Collagenous Tissue
9Procedural Steps
10Patient 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)
11(No Transcript)
12Epiduragram
L3
L3
L4
L4
Spill over to L4/5 level
L5
L5
12/17/07
13Placement of Trocar
AP
Oblique Laterial
14Laminotomy
15Tissue Excision
Rotation of device 90
16Cavitygram
cavitygram
advancing the catheter
17Outcome
- 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
18Materials 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.
19Results
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
20Results
- 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
21Demographics
- Of 253 patients from the meta-analysis
- Mean age 69.0
- 39.1 male
- 60.9 female
22Results
23Results
24Results
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)
25Conclusions
- 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