Open AccessNew Image-Guided Ultra-Minimally Invasive Lumbar Decompression Method: The mild® Procedure
Author(s) -
Timothy R. Deer
Publication year - 2010
Publication title -
pain physician
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.31
H-Index - 99
eISSN - 2150-1149
pISSN - 1533-3159
DOI - 10.36076/ppj.2010/13/35
Subject(s) - medicine , laminotomy , decompression , surgery , lumbar , percutaneous , adverse effect , epidural space , spinal canal , anesthesia , laminectomy , spinal cord , psychiatry
Background and Objectives: Lumbar canal stenosis is a common source of chronic lowback and leg pain. Minimally Invasive Lumbar Decompression (mild®) is a new minimallyinvasive treatment for pain relief from symptomatic central lumbar canal stenosis. Theprocedure involves limited percutaneous laminotomy and thinning of the ligamentumflavum in order to increase the critical diameter of the stenosed spinal canal. The objectiveof this technical report is to evaluate the acute safety of the mild procedure.Methods: Manual and electronic chart survey was conducted by 14 treating physicianslocated 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 productInstructions For Use. Those patients requiring lumbar decompression via tissue resectionat the perilaminar space, within the interlaminar space and at the ventral aspect of thelamina were treated. Data collected included any complications and/or adverse eventsoccurring during or immediately following the procedure prior to discharge.Results: Of 90 procedures reviewed, there were no major adverse events or complicationsrelated to the devices or procedure. No incidents of dural puncture or tear, bloodtransfusion, nerve injury, epidural bleeding, or hematoma were observed.Limitations: Data were not specifically collected; however, regardless of difficulty, in thisseries none of the procedures were aborted and none resulted in adverse events. Efficacyparameters were not collected in this safety survey.Conclusions: This review demonstrates the acute safety of the mild procedure with noreport of significant or unusual patient complications. To establish complication frequencyand longer-term safety profile associated with the treatment, additional studies arecurrently being conducted. Survey data on file at Vertos Medical, Inc.Key words: Spine, decompression, fluoroscopy, mild, stenosis, ligamentum