Background and Objectives: Lumbar canal stenosis is a common source of chronic low
back and leg pain. Minimally Invasive Lumbar Decompression (mild®) is a new minimally
invasive treatment for pain relief from symptomatic central lumbar canal stenosis. The
procedure involves limited percutaneous laminotomy and thinning of the ligamentum
flavum in order to increase the critical diameter of the stenosed spinal canal. The objective
of this technical report is to evaluate the acute safety of the mild procedure.
Methods: Manual and electronic chart survey was conducted by 14 treating physicians
located in 9 U.S. states on 90 consecutive patients who underwent the mild procedure.
Patients within local geographical practice areas were selected in keeping with product
Instructions For Use. Those patients requiring lumbar decompression via tissue resection
at the perilaminar space, within the interlaminar space and at the ventral aspect of the
lamina were treated. Data collected included any complications and/or adverse events
occurring during or immediately following the procedure prior to discharge.
Results: Of 90 procedures reviewed, there were no major adverse events or complications
related to the devices or procedure. No incidents of dural puncture or tear, blood
transfusion, nerve injury, epidural bleeding, or hematoma were observed.
Limitations: Data were not specifically collected; however, regardless of difficulty, in this
series none of the procedures were aborted and none resulted in adverse events. Efficacy
parameters were not collected in this safety survey.
Conclusions: This review demonstrates the acute safety of the mild procedure with no
report of significant or unusual patient complications. To establish complication frequency
and longer-term safety profile associated with the treatment, additional studies are
currently being conducted. Survey data on file at Vertos Medical, Inc.
Key words: Spine, decompression, fluoroscopy, mild, stenosis, ligamentum
Therapeutic Feasibility of Full Endoscopic Decompression in One- to Three-Level Lumbar Canal Stenosis via a Single Skin Port Using a New Endoscopic System, Percutaneous Stenoscopic Lumbar Decompression
