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Pain practice : the official journal of World Institute of Pain
Apr, 2025;25 (4): e70022.

Effects of an extended MRI approval of an implantable spinal cord stimulation device on compliance with manufacturer's recommendations.

Marco Reining, Dirk Winkler, Klaus Kirchhof, Joachim Boettcher, Michael Kretzschmar
Author Information
  1. Marco Reining: Department of Pain Medicine and Palliative Care, SRH Wald-Klinikum Gera GmbH, Gera, Germany. ORCID
  2. Dirk Winkler: Department of Neurosurgery, University Hospital Leipzig, Leipzig, Germany.
  3. Klaus Kirchhof: Department of Diagnostic and Interventional Radiology, SRH Wald-Klinikum Gera GmbH, Gera, Germany.
  4. Joachim Boettcher: Friedrich-Schiller-University of Jena, Jena, Germany.
  5. Michael Kretzschmar: Department of Pain Medicine and Palliative Care, SRH Wald-Klinikum Gera GmbH, Gera, Germany.
PMID: 40159636 DOI: 10.1111/papr.70022

Abstract

OBJECTIVE: The current approval for all available spinal cord stimulation (SCS) devices set several limitations for magnetic resonance imaging (MRI). As a result, most of the necessary examinations are not possible within the scope of the restrictive approvals and, if legally permitted, must be carried out off-label. This retrospective subgroup analysis investigates if the currently extended MRI approval of one specific device allows more MRI scans to be conducted within the manufacturer's recommendations.
MATERIALS AND METHODS: Technical MRI data (saved in the DICOM headers) and medical treatment data for all MRI examinations on patients with Proclaim® implantable pulse generators (IPG; Proclaim® spinal cord stimulation systems, Abbott Laboratories, Plano, TX, USA) were examined. Due to a major change in our standard operating procedures for MRI scans in 2019, the two time periods (before and after 2019) were separately analyzed.
RESULTS: We identified 62 MRI scans with the IPG. The entire implanted system was approved for MRI examinations in just over 50% of the cases, regardless of old and new approval. Options for lead placement were expanded in the new approval; however, this did not significantly improve the number of MR conditional devices. By contrast, for a higher specific absorption rate, significantly more scans within the recommendations are possible in Period 2 (p = 0.011). However, the number of possible scans did not reach statistical significance in Period 1 (p = 0.078). No device-related adverse events were noted.
CONCLUSION: The new MRI approval is suitable for performing more scans within the manufacturer's specifications. Cervical leads remain problematic because longer leads are required, and the lower impedances inhibit the MRI mode.

Keywords

health services research implantable neurostimulators magnetic resonance imaging patient safety spinal cord stimulation

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Grants

  1. /SRH Wald-Klinikum Gera GmbH

MeSH Term

Humans
Magnetic Resonance Imaging
Spinal Cord Stimulation
Retrospective Studies
Device Approval
Female
Male
Middle Aged
Implantable Neurostimulators
Electrodes, Implanted
Journal Article

Word Cloud

Created with Highcharts 10.0.0MRIapprovalscansspinalcordstimulationwithinexaminationspossiblemanufacturer'srecommendationsimplantablenewdevicesmagneticresonanceimagingextendedspecificdevicedataProclaim®IPG2019significantlynumberPeriodp = 0leadsOBJECTIVE:currentavailableSCSsetseverallimitationsresultnecessaryscoperestrictiveapprovalslegallypermittedmustcarriedoff-labelretrospectivesubgroupanalysisinvestigatescurrentlyoneallowsconductedMATERIALSANDMETHODS:TechnicalsavedDICOMheadersmedicaltreatmentpatientspulsegeneratorssystemsAbbottLaboratoriesPlanoTXUSAexaminedDuemajorchangestandardoperatingprocedurestwotimeperiodsseparatelyanalyzedRESULTS:identified62entireimplantedsystemapprovedjust50%casesregardlessoldOptionsleadplacementexpandedhoweverimproveMRconditionalcontrasthigherabsorptionrate2011Howeverreachstatisticalsignificance1078device-relatedadverseeventsnotedCONCLUSION:suitableperformingspecificationsCervicalremainproblematiclongerrequiredlowerimpedancesinhibitmodeEffectscompliancehealthservicesresearchneurostimulatorspatientsafety

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