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Spinal Cord Stimulation
Effect of a Novel Fixation Method for Spinal Cord Stimulators
Article first published online: 18 SEP 2012
© 2012 International Neuromodulation Society
Neuromodulation: Technology at the Neural Interface
Volume 16, Issue 5, pages 449–453, September/October 2013
How to Cite
McRoberts, W. P., Wu, P. and Bentley, I. (2013), Effect of a Novel Fixation Method for Spinal Cord Stimulators. Neuromodulation: Technology at the Neural Interface, 16: 449–453. doi: 10.1111/j.1525-1403.2012.00499.x
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.
Conflict of Interest: Author Ishmael Bentley is a full-time employee of Anulex Technologies, Inc. The other authors reported no conflicts of interest.
- Issue published online: 29 OCT 2013
- Article first published online: 18 SEP 2012
- Received: March 23, 2012 Revised: June 17, 2012 Accepted: July 14, 2012
- case series;
- failed back surgery syndrome;
- lead migration;
- spinal cord stimulation
Introduction: Spinal cord stimulation is a well-established treatment for recalcitrant pain syndromes such as failed back surgery syndrome. Techniques minimizing surgical time and incision size and increasing lead stability are of great value to both the patient and implanting physician. We present a consecutive case series review of ten permanent percutaneous spinal cord implants utilizing a novel lead fixation device. The purpose of this case series review is to present initial findings of the minimized incision size and thoughts surrounding the new device and technique.
Case Series Report: Ten cases were performed utilizing the new device (fiXate) and technique. Incision size was dictated by adequate visualization of the fascial stratum as well as technical working space required for lead fixation and redirection to the generator pocket. Each spinal cord stimulator lead was affixed to the thoracodorsal fascia utilizing the novel device.
Discussion: In this consecutive series, the average midline incision size was 2.2 cm (range = 1.9-2.6 cm) which is greatly minimized through the use of the device. Not only may fiXate directly affect incision size, operating room and anesthesia time may also be lessened due to the semiautomated nature of the device. Of the cases performed, there were no complications or adverse events. Of note, there have been no reports of lead migrations during this case series, the average follow-up time being 18 weeks (range 11-26 weeks).
Conclusion: These data suggest a new method of fixation can be utilized for percutaneous spinal cord stimulation that allows a reduction in incision size. Intuitively, reduction in incision size is relevant with regard to tissue morbidity and may also have implications with regard to infection. Use of the device may also reduce operating room and anesthesia time as well as provide greater stability than standard suture.