BACKGROUND AND OBJECTIVES: Lumbar canal stenosis is a common source of chronic low back and leg pain. Minimally Invasive Lumbar Decompression (mild(R)) 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.
BACKGROUND AND OBJECTIVES: Lumbar canal stenosis is a common source of chronic low back and leg pain. Minimally Invasive Lumbar Decompression (mild(R)) 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.
Authors: Timothy R Deer; Jay S Grider; Jason E Pope; Tim J Lamer; Sayed E Wahezi; Jonathan M Hagedorn; Steven Falowski; Reda Tolba; Jay M Shah; Natalie Strand; Alex Escobar; Mark Malinowski; Anjum Bux; Navdeep Jassal; Jennifer Hah; Jacqueline Weisbein; Nestor D Tomycz; Jessica Jameson; Erika A Petersen; Dawood Sayed Journal: J Pain Res Date: 2022-05-05 Impact factor: 2.832
Authors: Ken P Ehrhardt; Susan M Mothersele; Andrew J Brunk; Jeremy B Green; Mark R Jones; Craig B Billeaud; Alan David Kaye Journal: Curr Pain Headache Rep Date: 2018-03-19
Authors: Nagy A Mekhail; Shrif J Costandi; Sherif Armanyous; Ricardo Vallejo; Lawrence R Poree; Lora L Brown; Stanley Golovac; Timothy R Deer Journal: Med Devices (Auckl) Date: 2020-06-04