1. mild Decompression for the Treatment of Lumbar Spinal Stenosis

2. Disclosure
I am an inventor of the mild procedure and instruments & an investor in Vertos Medical Inc.

3. Purpose
To evaluate the safety and efficacy of minimally invasive lumbar decompression, the mild procedure, for the treatment of lumbar spinal stenosis.

4. Lumbar Spinal Stenosis
1.4 M people diagnosed with LSS each year in the USA & growing due to aging boomers
Present in ~10% of all adults > 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

5. Severe Spinal Stenosis
Thecal sac significantly compressed
Area ≤85 mm2
AP ~6-8 mm
Ligament ≥4 mm
Usually symptomatic

6. The Procedure: mild Minimally Invasive Lumbar Decompression
A new percutaneous procedure that addresses a root cause of patient’s 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

7. mild Instruments

8. Debulk Collagenous Tissue
Ligament Decompression
Laminotomy to open pathway
Leave Ventral Healthy Fibers Intact

9. Procedural Steps

10. 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 (<24 hour hospitalization)

12. Epiduragram L3 L3 L4 L4
Spill over to L4/5 level L5 L5
12/17/07

13. Placement of Trocar AP
Oblique Laterial

14. Laminotomy

15. Tissue Excision
Rotation of device 90°

16. advancing the catheter
Cavitygram
cavitygram
advancing the catheter

17. 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 couldn’t do before

18. Materials and Methods
A meta-analysis of 9 IRB approved clinical patient series from multiple institutions in the USA and Canada evaluated > 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 2008;358:
Clinical follow-up ranged from six weeks to one year for these series.

19. Results NEJM 2008;358:794-810 Pain Physician 2010; 13:35-41
* Denotes 3 point responders only (7/10 patients)
** All data is on file at Vertos Medical and verified by the clinician researchers
NEJM 2008;358:
Pain Physician 2010; 13:35-41

20. 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 (p< , t-test for correlated samples) three-month follow-up pain & disability score improvement from baseline

21. Demographics Of 253 patients from the meta-analysis: Mean age 69.0
39.1% male
60.9% female

22. Results

23. Results

24. 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%
BPBS
4.3
1.6
(2.7) 62.8%
ODI
(17.10)
(21.40)

25. 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