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

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Title: Effects of an extended MRI approval of an implantable spinal cord stimulation device on compliance with manufacturer's recommendations.
Authors: Reining, Marco, Winkler, Dirk, Kirchhof, Klaus, Boettcher, Joachim, Kretzschmar, Michael
Source: Pain Practice. Apr2025, Vol. 25 Issue 4, p1-8. 8p.
Subjects: Patient safety, Research funding, Magnetic resonance imaging, Artificial implants, Retrospective studies, Descriptive statistics, Chi-squared test, Professions, Commercial product evaluation, Medical equipment, Medical records, Acquisition of data, Neural stimulation, Data analysis software, Spinal cord, New product development laws, Legal compliance, Electrodes, Time
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. [ABSTRACT FROM AUTHOR]
Copyright of Pain Practice is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
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  Data: Effects of an extended MRI approval of an implantable spinal cord stimulation device on compliance with manufacturer's recommendations.
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  Data: <searchLink fieldCode="AR" term="%22Reining%2C+Marco%22">Reining, Marco</searchLink><br /><searchLink fieldCode="AR" term="%22Winkler%2C+Dirk%22">Winkler, Dirk</searchLink><br /><searchLink fieldCode="AR" term="%22Kirchhof%2C+Klaus%22">Kirchhof, Klaus</searchLink><br /><searchLink fieldCode="AR" term="%22Boettcher%2C+Joachim%22">Boettcher, Joachim</searchLink><br /><searchLink fieldCode="AR" term="%22Kretzschmar%2C+Michael%22">Kretzschmar, Michael</searchLink>
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  Data: <searchLink fieldCode="JN" term="%22Pain+Practice%22">Pain Practice</searchLink>. Apr2025, Vol. 25 Issue 4, p1-8. 8p.
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  Data: <searchLink fieldCode="DE" term="%22Patient+safety%22">Patient safety</searchLink><br /><searchLink fieldCode="DE" term="%22Research+funding%22">Research funding</searchLink><br /><searchLink fieldCode="DE" term="%22Magnetic+resonance+imaging%22">Magnetic resonance imaging</searchLink><br /><searchLink fieldCode="DE" term="%22Artificial+implants%22">Artificial implants</searchLink><br /><searchLink fieldCode="DE" term="%22Retrospective+studies%22">Retrospective studies</searchLink><br /><searchLink fieldCode="DE" term="%22Descriptive+statistics%22">Descriptive statistics</searchLink><br /><searchLink fieldCode="DE" term="%22Chi-squared+test%22">Chi-squared test</searchLink><br /><searchLink fieldCode="DE" term="%22Professions%22">Professions</searchLink><br /><searchLink fieldCode="DE" term="%22Commercial+product+evaluation%22">Commercial product evaluation</searchLink><br /><searchLink fieldCode="DE" term="%22Medical+equipment%22">Medical equipment</searchLink><br /><searchLink fieldCode="DE" term="%22Medical+records%22">Medical records</searchLink><br /><searchLink fieldCode="DE" term="%22Acquisition+of+data%22">Acquisition of data</searchLink><br /><searchLink fieldCode="DE" term="%22Neural+stimulation%22">Neural stimulation</searchLink><br /><searchLink fieldCode="DE" term="%22Data+analysis+software%22">Data analysis software</searchLink><br /><searchLink fieldCode="DE" term="%22Spinal+cord%22">Spinal cord</searchLink><br /><searchLink fieldCode="DE" term="%22New+product+development+laws%22">New product development laws</searchLink><br /><searchLink fieldCode="DE" term="%22Legal+compliance%22">Legal compliance</searchLink><br /><searchLink fieldCode="DE" term="%22Electrodes%22">Electrodes</searchLink><br /><searchLink fieldCode="DE" term="%22Time%22">Time</searchLink>
– Name: Abstract
  Label: Abstract
  Group: Ab
  Data: 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. [ABSTRACT FROM AUTHOR]
– Name: AbstractSuppliedCopyright
  Label:
  Group: Ab
  Data: <i>Copyright of Pain Practice is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
PLink https://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=pbh&AN=184297892
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      – Type: doi
        Value: 10.1111/papr.70022
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      – Code: eng
        Text: English
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      Pagination:
        PageCount: 8
        StartPage: 1
    Subjects:
      – SubjectFull: Patient safety
        Type: general
      – SubjectFull: Research funding
        Type: general
      – SubjectFull: Magnetic resonance imaging
        Type: general
      – SubjectFull: Artificial implants
        Type: general
      – SubjectFull: Retrospective studies
        Type: general
      – SubjectFull: Descriptive statistics
        Type: general
      – SubjectFull: Chi-squared test
        Type: general
      – SubjectFull: Professions
        Type: general
      – SubjectFull: Commercial product evaluation
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      – SubjectFull: Medical equipment
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      – SubjectFull: Medical records
        Type: general
      – SubjectFull: Acquisition of data
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      – SubjectFull: Neural stimulation
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      – SubjectFull: Data analysis software
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      – SubjectFull: Spinal cord
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      – SubjectFull: Time
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    Titles:
      – TitleFull: Effects of an extended MRI approval of an implantable spinal cord stimulation device on compliance with manufacturer's recommendations.
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              Text: Apr2025
              Type: published
              Y: 2025
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