Vertos Medical has developed a comprehensive clinical research program to validate the safety and effectiveness of the mild procedure. Five hundred forty-two patients have been enrolled in 11 clinical studies at leading interventional pain institutions in the U.S. There have been 16 physician-reviewed clinical journal articles published on mild. Data have shown that mild patients are able to stand longer and walk farther with less pain.1 No major complications related to the devices or the procedure have been reported in any clinical trial.2
Key Study Outcomes: Proven Long-term Efficacy
Functional Outcome Improvement – Cleveland Clinic Study at 1 Year1
Standing time increase:
From 8 min. to 56 min.
Walking distance increase:
From 246 ft. to 3,956 ft.
Long-term Efficacy – MiDAS I at 1 Year5,7-8
VAS (Visual Analog Scale) measures
pain via a 10-point scale.
Pain reduced in 79% of patients at 1 year
Mean pain reduced by 53%
ODI (Oswestry Disability Index) measures
mobility via a questionnaire.
Patients who achieved pain reduction
Mean mobility increased by 34%
Completed Studies (10)
- MiDAS I (mild Decompression Alternative to open Surgery): 78-patient, open-label, single-arm, prospective, multi-center, IRB-approved study.
Mekhail, Nagy, et al. (2012), Long-Term Results of Percutaneous Lumbar Decompression mild for Spinal Stenosis. Pain Practice, 12(6): 184–193. doi: 10.1111/j.1533-2500.2011.00481.x
Chopko, Bohdan W., et. al. (2010), MiDAS I (mild Decompression Alternative to Open Surgery): A Preliminary Report of a Prospective, Multi-Center Clinical Study. Pain Physician, 13:369-378, ISSN 1533-3159.
- Cleveland Clinic Functional Outcomes Study: 40-patient, single-site, prospective, IRB-approved study.
Mekhail, Nagy, et al. (2012), Functional and Patient-Reported Outcomes in Symptomatic Lumbar Spinal Stenosis Following Percutaneous Decompression. Pain Practice, 12(6): 417–425. doi: 10.1111/j.1533-2500.2012.00565.x
- ESI-I Trial: 38-patient, single-site, randomized, double-blind, prospective, IRB-approved study.
Brown, Lora L. (2012), A Double-blind, Randomized, Prospective Study of Epidural Steroid Injection vs. The mild Procedure in Patients with Symptomatic Lumbar Spinal Stenosis. Pain Practice, 12: 333–341. doi: 10.1111/j.1533-2500.2011.00518.x
- MiDAS II: 55-patient, open label, single-arm, multi-center, prospective, IRB-approved study.
- Single-Site, Wong: 17-patient, single-site, prospective study.
Wong, Wade H. M. (2012), mild Interlaminar Decompression for the Treatment of Lumbar Spinal Stenosis. Procedure Description and Case Series With 1-year Follow-up. Clinical Journal of Pain, 28(6):534-538.
- Surgery Intolerant Trial: 14-patient, single-site, open label, single-arm, prospective, IRB-approved study.
Chopko, Bohdan W. (2011) A Novel Method for Treatment of Lumbar Spinal Stenosis in High-risk Surgical Candidates: Pilot Study Experience with Percutaneous Remodeling of Ligamentum Flavum and Lamina. Journal of Neurosurgery: Spine, 14:46–50.
- Single-Site, Basu: 27-patient, single-site, prospective, IRB-approved study.
Basu, Sanghamitra. (2012) mild Procedure: Single-Site Experience Prospective IRB Study. Clinical Journal of Pain, 28: 254-258. doi: 10.1097/AJP.0b013e31822bb344.
- Prospective Patient Series: 46-patient, single-site, open label, single-arm, prospective, IRB-approved study.
Deer, Timothy, et al. (2012), Study of Percutaneous Lumbar Decompression and Treatment Algorithm for Patients Suffering from Neurogenic Claudication. Pain Physician, 15: 451-460, ISSN 1533-3159.
- Single-Site Series: 42-patient, single-site, retrospective, IRB-approved study.
Lingreen, Richard, et al. (2010), Retrospective Review of Patient Self Reported Improvement and Post-Procedure Findings for mild (Minimally Invasive Lumbar Decompression). Pain Physician, 13:555-560, ISSN 1533-3159.
- mild Acute Safety Study: 90-patient, multi-center, retrospective study.
Deer, Timothy, et al. (2010), New Image-Guided Ultra-Minimally Invasive Lumbar Decompression Method: The mild Procedure. Pain Physician, 13:35-41, ISSN 1533-3159.
Ongoing Study (1)
- MiDAS ECO: 138-patient, multi-site, prospective, randomized, IRB-approved study; enrollment complete.
Detailed study methodologies are available upon request.