- More than 15,000 mild® cases performed in over 45 states.
11 Clinical Trials
Completed
1. MiDAS I (mild® Decompression Alternative to open Surgery): 78-patient, open-label, single-arm, prospective, multi-center, IRB-approved study.
2. Cleveland Clinic Functional Outcomes Study: 40-patient, single-site, prospective, IRB-approved study.
3. ESI-I Trial: 38-patient, single-site, randomized, double-blind, prospective, IRB-approved study.
4. MiDAS II: 55-patient, open label, single-arm, multi-center, prospective, IRB-approved study.
5. Long-Term Single-Site: 17-patient, single-site, prospective study.
6. Surgery Intolerant Trial: 14-patient, single-site, open label, single-arm, prospective, IRB-approved study.
7. Six-Month Single-Site: 27-patient, single-site, prospective, IRB-approved study.
8. Prospective Cohort Series: 46-patient, single-site, open label, single-arm, prospective, IRB-approved study.
9. Single-Site Series: 42-patient, single-site, retrospective, IRB-approved study.
10. mild® Acute Safety Study: 90-patient, multi-center, retrospective study.
Ongoing
11. MiDAS III: 138-patient, multi-site, prospective, randomized, IRB-approved study; enrollment complete.
16 Peer-Reviewed Journal Articles
Article Title / Article Summary
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 / One year post-treatment, a single-site, 40-patient, prospective study demonstrated statistically significant improvement in pain (VAS imp. 3.5 pts.), standing time (inc. from 8 to 56 min.) and walking distance (inc. from 246' to 3,956') with no device or procedure-related serious complications.
Levy, Robert, et al. (2012), Systematic Safety Review and Meta-Analysis of Procedural Experience Using Percutaneous Access to Treat Symptomatic Lumbar Spinal Stenosis. Pain Medicine, 13(12): 1554-1561. doi: 10.1111/j.1526-4637.2012.01504.x / A systematic safety review and meta-analysis of mild® procedural experience of 373 patients across 32 sites demonstrated that there were no reports of major device or procedure-related adverse events. The study also showed statistically significant improvement in pain (VAS imp. 3.9 pts.) and mobility (ODI imp. 16.0 pts.) in 134 patients at one year.
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(5): 333–341. doi: 10.1111/j.1533-2500.2011.00518.x / A single-site, 38-patient, double-blind, randomized, prospective study demonstrated mild® provides statistically significantly better pain reduction and improved functional mobility vs. treatment with ESI. At 12 weeks, patients in the mild® cohort experienced a statistically significant improvement in pain (VAS imp. 2.9 pts.) and mobility (ODI imp. 18.6 pts.) with no device or procedure-related serious complications.
Chopko, Bohdan (2013), Long-term Results of Percutaneous Lumbar Decompression for LSS: Two-Year Outcomes. Clinical Journal of Pain, doi: 10.1097/AJP.0b013e31827fb803 [Epub ahead of print]. / Two years post-treatment, a prospective study report including 11 sites and 45 patients demonstrated statistically significant improvement in pain (VAS imp. 3.8 pts.) and mobility (ODI imp. 11.6 pts.) with no device or intra-procedure adverse events. This is the longest reported multi-center follow-up on patients treated with the mild® procedure.
Mekhail, Nagy, et al. (2012), Long-Term Results of Percutaneous Lumbar Decompression mild® for Spinal Stenosis. Pain Practice, 12(3): 184–193. doi: 10.1111/j.1533-2500.2011.00481.x / One year post-treatment, a prospective study report including 11 sites and 58 patients demonstrated statistically significant improvement in pain (VAS imp. 2.9 pts.) and mobility (ODI imp. 11.9 pts.) with no device or procedure-related serious complications.
Deer, Timothy, et al. (2012), Study of Percutaneous Lumbar Decompression and Treatment Algorithm for Patients Suffering from Neurogenic Claudication. Pain Physician, 15(6): 451-460, ISSN 1533-3159. / One year post-treatment, a single-site, 46-patient, prospective study demonstrated statistically significant improvement in pain (VAS imp. 2.9 pts.) and mobility (ODI imp. 17.4 pts.) with no reports of major device or procedure-related adverse events. One-year follow-up was not significantly different from interim results, indicating that improvement following treatment as early as 12 weeks was maintained through one year.
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. / One year post-treatment, a single-site, 17-patient, prospective study demonstrated statistically significant improvement in pain (VAS imp. 5.4 pts.) and mobility (ODI imp. 26.6 pts.) with no device or procedure-related serious complications.
Basu, Sanghamitra. (2012), mild® Procedure: Single-Site Experience Prospective IRB Study. Clinical Journal of Pain, 28(3): 254-258. doi: 10.1097/AJP.0b013e31822bb344. / A single-site, 27-patient, prospective study demonstrated statistically significant improvement in pain (VAS imp. 5.2 pts.) and mobility (ODI imp. 24.0 pts.) six months post-treatment, with no device or procedure-related serious complications.
Schomer, Donald, et al. (2011), mild® Lumbar Decompression for the Treatment of Lumbar Spinal Stenosis. Neuroradiology Journal, 24(4): 620-626. / A 17-site, 107-patient, meta-analysis demonstrated statistically significant improvement in pain (VAS imp. 3.5 pts.) and mobility (ODI imp. 17.1 pts.) with no device or procedure-related serious complications.
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(4): 369-378, ISSN 1533-3159. / A 14-site, 78-patient, prospective study demonstrated statistically significant improvement in pain (VAS imp. 3.6 pts.) and mobility (ODI imp. 17.9 pts.) with no device or procedure-related serious complications.
Deer, Timothy, et al. (2010), New Image-Guided Ultra-Minimally Invasive Lumbar Decompression Method: The mild® Procedure. Pain Physician, 13(1): 35-41, ISSN 1533-3159. / A safety survey of 14 treating physicians on 90 consecutive mild® patients for whom there were no major adverse events or complications related to the devices or procedure.
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(6): 555-560, ISSN 1533-3159. / A single-site, 42 patient, retrospective study demonstrated statistically significant improvement in pain (VAS imp. 3.8 pts.) and improvement in function as assessed by ability to stand and ambulate, with no device or procedure-related major adverse events.
Deer, Timothy. (2012), Minimally Invasive Lumbar Decompression for the Treatment of Spinal Stenosis of the Lumbar Spine. Pain Management, 2(5): 457-465, ISSN 1758-1869. / A review of the technique and current literature regarding the efficacy and safety of the mild® procedure. Patient outcomes post-mild® were statistically significantly improved in both pain intensity and physical function, with excellent safety results and no major device- or procedure-related complications. Compared to published decompressive surgery safety results, mild® patients experienced comparable outcomes with significantly fewer serious related adverse events.
Chen, Hamilton, et al. (2012), mild® Procedure for Lumbar Decompression: A Review. Pain Practice, 13(2): 146-153. doi:10.1111/j.1533-2500.2012.00574.x / Current literature review regarding the efficacy, safety, and cost-effectiveness of the mild® procedure with comparison to surgical treatment demonstrated a similar level of symptom relief and a significantly better safety profile with mild®.
Deer, Timothy, et al. (2011), Minimally Invasive Lumbar Decompression for Spinal Stenosis. Journal of Neurosurgical Review, 1(S1): 29-32. / A review of the current literature regarding the efficacy, safety, and cost-effectiveness of the mild® procedure concluded that pain can be safely, and effectively educed and functionality improved, with minimal change of spinal biomechanics and stability in LSS patients.
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(1): 46–50. /
A single-site, 14-patient, prospective study of high-risk surgical patients demonstrated a statistically significant improvement in VAS scores with a reduction in pain of 53% (VAS imp. 3.9 pts.) at an average 23.5 weeks following the procedure compared with preoperative levels. The ODI score improvement was not statistically significant. The lack of improvement in ODI scores was not surprising, given the fact that many of the patients had physiologically limiting coexistent issues, such as oxygen-dependent pulmonary fibrosis, prior stroke, and systemic malignancies.