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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. Eight hundred eighty-seven patients have been enrolled in 12 clinical studies at leading interventional pain institutions in the U.S. A new study of 302 Medicare patients is underway (MiDAS ENCORE). There have been more than 17 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 device-related complications 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 (11)

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


Ongoing Study

  • MiDAS ENCORE: 302-patient, prospective, multi-center, randomized controlled clinical study; enrollment complete.
    Related publications:
    Benyamin, R., et al. (2015), MiDAS ENCORE: Randomized Controlled Study Design and Protocol, Pain Physician, 18:307-316, ISSN 1533-3159.
    Staats, P., et al. (2016), MiDAS ENCORE: Randomized Controlled Clinical Trial Report of 6-Month Results, Pain Physician, 19: 25-37, ISSN 1533-3159.
    Benyamin, R., et al. (2016), mild is an Effective Treatment for Lumbar Spinal Stenosis with Neurogenic Claudication: MiDAS ENCORE Randomized Controlled Trial, Pain Physician, 19: 229-242, ISSN 1533-3159.


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.