{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,2]],"date-time":"2026-06-02T19:08:09Z","timestamp":1780427289377,"version":"3.54.1"},"reference-count":31,"publisher":"BMJ","issue":"3","funder":[{"DOI":"10.13039\/100007311","name":"Cleveland Clinic","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100007311","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["Reg Anesth Pain Med"],"accepted":{"date-parts":[[2025,1,24]]},"published-print":{"date-parts":[[2026,3]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Current treatment modalities of lumbar spinal stenosis range from conservative medical management and physical therapy to open surgical decompression. Minimally invasive lumbar decompression (MILD) and Superion interspinous spacers (SISS) Vertiflex offer the promise of effective pain relief with shorter recovery time and lesser potential complications compared with open surgical decompression procedures and general anesthesia. Despite their increasing utilization, their complication profile is not well established in the literature.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We searched the FDA\u2019s Manufacturer and User facility Device Experience (MAUDE) database for all entries on MILD product code \u2018HRX\u2019 and SISS product code \u2018NQO\u2019. MAUDE database was queried from 2010 to 2021. Duplicate entries were removed, and complications were classified based on the event descriptions.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>For the MILD procedure, a total of 10 entries were found in the MAUDE database. Among these, 8 were classified as surgical complications and 2 were device related. On the other hand, a total of 919 reports were found in the MAUDE database for Vertiflex, with 385 medical device reports were included in the analysis. Device-related were the most reported complication, accounting for 189 cases.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>As with any new intervention, we must proceed with caution and evaluate the procedure performance over time. Such data should aid physicians to make informed decisions before choosing either technique for their patients. The findings from this study provide insight into the complication profile associated with both MILD and Vertiflex procedures, highlighting the need for continued evaluation and careful consideration in clinical decision-making.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/rapm-2024-105706","type":"journal-article","created":{"date-parts":[[2025,2,12]],"date-time":"2025-02-12T13:15:38Z","timestamp":1739366138000},"page":"300-308","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":3,"title":["Analysis of complications of minimally invasive approaches for symptomatic lumbar spinal stenosis"],"prefix":"10.1136","volume":"51","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3823-9610","authenticated-orcid":false,"given":"Nagy","family":"Mekhail","sequence":"first","affiliation":[{"name":"Pain Management, Cleveland Clinic, Cleveland, Ohio, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0864-9846","authenticated-orcid":false,"given":"Shrif","family":"Costandi","sequence":"additional","affiliation":[{"name":"Pain Management, Cleveland Clinic, Cleveland, Ohio, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mina","family":"Botros","sequence":"additional","affiliation":[{"name":"Pain Management, Cleveland Clinic, Cleveland, Ohio, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Junaid","family":"Mukhdomi","sequence":"additional","affiliation":[{"name":"Pain Labs, New Albany, Ohio, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter","family":"Yassa","sequence":"additional","affiliation":[{"name":"Pain Management, Cleveland Clinic, Cleveland, Ohio, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Taif","family":"Mukhdomi","sequence":"additional","affiliation":[{"name":"Pain Labs, New Albany, Ohio, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2025,2,12]]},"reference":[{"key":"2026031205150981000_51.3.300.1","doi-asserted-by":"crossref","DOI":"10.1136\/bmj.h6234","article-title":"Management of lumbar spinal stenosis","volume":"352","author":"Lurie","year":"2016","journal-title":"BMJ"},{"key":"2026031205150981000_51.3.300.2","doi-asserted-by":"crossref","first-page":"E857","DOI":"10.1097\/BRS.0000000000001635","article-title":"Surgical Versus Nonsurgical Treatment for Lumbar Spinal Stenosis","volume":"41","author":"Zaina","year":"2016","journal-title":"Spine (Phila Pa 1986)"},{"key":"2026031205150981000_51.3.300.3","doi-asserted-by":"publisher","DOI":"10.1111\/j.1533-2500.2012.00565.x"},{"key":"2026031205150981000_51.3.300.4","doi-asserted-by":"publisher","DOI":"10.1097\/AJP.0b013e31823aaa9d"},{"key":"2026031205150981000_51.3.300.5","doi-asserted-by":"publisher","DOI":"10.2174\/1874325001105010361"},{"key":"2026031205150981000_51.3.300.6","doi-asserted-by":"crossref","first-page":"4628","DOI":"10.1007\/s12325-021-01875-8","article-title":"A Comprehensive Review of Novel Interventional Techniques for Chronic Pain: Spinal Stenosis and Degenerative Disc Disease-MILD Percutaneous Image Guided Lumbar Decompression, Vertiflex Interspinous Spacer, MinuteMan G3 Interspinous-Interlaminar Fusion","volume":"38","author":"Kaye","year":"2021","journal-title":"Adv Ther"},{"key":"2026031205150981000_51.3.300.7","doi-asserted-by":"publisher","DOI":"10.1586\/erd.11.24"},{"key":"2026031205150981000_51.3.300.8","article-title":"The Use of Vertiflex Interspinous Spacer Device in Patients With Lumbar Spinal Stenosis and Concurrent Medical Comorbidities","volume":"11","author":"Hartman","year":"2019","journal-title":"Cureus"},{"key":"2026031205150981000_51.3.300.9","doi-asserted-by":"crossref","unstructured":"Bagley C , MacAllister M , Dosselman L , et al . 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