Skip to content

 

Clinical Research

 

Clinical research

Vertos Medical understands the value and importance of clinical evidence and has produced over a decade's worth of robust data validate the safety and effectiveness of the mild procedure.

20,000 Patients Treated

13 Clinical Studies
conducted at leading interventional pain institutions across the U.S.

20+ Peer-Reviewed Journal Articles
published to date

Level 1 Data Available
from CMS-approved MiDAS ENCORE Study6


Low Complication Rates:

  • Clinically demonstrated equivalent safety profile to epidural steroid injections (ESI).6
  • No major device-related complications reported in any clinical trial.2
  • Adverse event rate <0.1% in more than 20,000 commercial cases.

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.

Completed Studies (11)

  • MiDAS I: 78-patient, prospective, multi-center study.
  • Cleveland Clinic Functional Outcomes Study: 40-patient, prospective, single-center study.
  • Double-blind, prospective, randomized controlled study of epidural steroid injection vs. mild (Brown): 38-patient, single-center study.
  • MiDAS II: 55-patient, prospective, multi-center study.
  • mild case series (Wong): 17-patient, multi-center study.
  • Surgery Intolerant Trial (Chopko): 14-patient, prospective, single-center study.
  • mild procedure: Single-site prospective IRB study (Basu): 27-patient, prospective, single-center study.
  • Prospective patient series (Deer et al): 46-patient, prospective, single-center study.
  • Single-site series (Lingreen and Grider): 42-patient, retrospective, single-center study.
  • mild Acute Safety Study: 90-patient, retrospective, multi-center study.
  • MiDAS III: 138-patient, prospective, multi-center, randomized controlled study.


Ongoing Studies (2)

  • mild Percutaneous Image-Guided Lumbar Decompression: A Medicare Claims Study; now enrolling.
  • MiDAS ENCORE: 302-patient, prospective, multi-center, randomized controlled clinical study; enrollment complete.

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