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A Case Series Review of Spinal Cord Stimulation Migration Rates With a Novel Fixation Device

Authors


  • Conflict of Interest: Rafael Justiz is a medical consultant for Anulex Technologies, Inc. Ishmael Bentley is a technical writing consultant for and a stockholder in Anulex Technologies, Inc. Independent contract services were utilized for organization and analysis of the data.
  • For more information on author guidelines, an explanation of our peer review process, and conflict of interest informed consent policies, please go to http://www.wiley.com/bw/submit.asp?ref=1094-7159&site=1
  • Disclosures: Products used in this study are commercially available through the 510(k) process. The package insert(s) should be consulted for a complete listing of warnings, adverse reactions, contraindications, and instructions for use of the products described.

Abstract

Introduction

A retrospective review of a consecutive case series of 66 permanent spinal cord stimulation implants utilizing a novel tissue fixation device was performed. The purpose of this case series review is to examine the impact of a novel lead anchor to tissue fixation system and determine if it is a viable alternative to standard tissue fixation methods.

Case Series Report

Sixty-six cases were performed utilizing a novel method of lead anchor tissue fixation. Cases performed included cervical and thoracolumbar. For the majority of the 66 cases, two spinal cord stimulator leads and two SwiftLock lead anchors in conjunction with the novel method of tissue fixation were utilized.

Results

A retrospective review indicated no reports of lead migration during this case series, the mean follow-up time being 38 weeks (range 10–68 weeks). In addition, there were zero reported complications or untoward effects due to use of the novel device and technique.

Discussion

Overall complication rates for SCS have been reported in the range of 30–40%, with hardware-related complications contributing a significant percentage to the overall complication rate. Lead anchoring techniques still rely heavily on the experience and skill of the implanting physician. The novel device and method utilized in this case series to aid in anchoring leads demonstrated good results with no observed postoperative complications.

Conclusion

These data suggest this novel method of tissue fixation may be a viable alternative for fixation of spinal cord stimulator leads to soft tissue. In this case series there were no reported incidents of migration or complications related to the novel device.

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