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Clinical Research

 

Clinical research

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. A new study of 300 Medicare patients is underway (MiDAS ENCORE). There have been more than 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 – Meta-Analysis at 1 Year5,7-8


VAS (Visual Analog Scale) measures
pain via a 10-point scale.


Pain reduced in 81% of patients at 1 year
Mean pain reduced by 53%


ODI (Oswestry Disability Index) measures
mobility via a questionnaire.


Patients who achieved pain reduction
also experienced:
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.
    Related publications:
    Levy, R., et al. (2012), Systematic safety review and meta-analysis of procedural experience using percuanteous access to treat symptomatic lumbar spinal stenosis. Pain Medicine, 13(12), 1554-1561. doi:10.1111/j.1526-4637.2012.01504.
    Chopko, B. (2013), Long-term Results of Percutaneous Lumbar Decompression for LSS Two-Year Outcomes. Clinical Journal of Pain. doi: 10.1097/AJP.0b013e31827fb803 [Advanced online publication].                                                                                                                                     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.
    Related publication:
    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.
    Related publication:
    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.
    Related publication:
    Levy, R., et al. (2012), Systematic safety review and meta-analysis of procedural experience using percuanteous access to treat symptomatic lumbar spinal stenosis. Pain Medicine, 13(12), 1554-1561. doi:10.1111/j.1526-4637.2012.01504. 

  • Single-Site, Wong: 17-patient, single-site, prospective study.
    Related publication:
    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.
    Related publication:
    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.
    Related publication:
    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.
    Related publications:
    Levy, R., et al. (2012), Systematic safety review and meta-analysis of procedural experience using percuanteous access to treat symptomatic lumbar spinal stenosis. Pain Medicine, 13(12), 1554-1561. doi:10.1111/j.1526-4637.2012.01504.
    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.
    Related publication:
    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.
    Related publication:
    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 Studies (2)

  • MiDAS III: 138-patient, multi-site, prospective, randomized, IRB-approved study; enrollment complete.

  • MiDAS ENCORE: 300-patient, prospective, multi-center, randomized controlled clinical study; now enrolling.


Detailed study methodologies are available upon request.

The mild Device Kit has been cleared by the U.S. Food and Drug Administration (FDA) for decompression of the lumbar spine.