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ESRA19-0323 Primary cell longevity for spinal cord stimulation: results from the product surveillance registry
  1. J Tinsley1,
  2. S Scheffler2,
  3. JS Menk3,
  4. R Slangen4,
  5. E Buchser5,
  6. S Eldabe6 and
  7. T Weaver7
  1. 1Medtronic International Trading Sarl, Clinical Research, Tolochenaz, Switzerland
  2. 2Medtronic International Trading Sarl, Health Economics and Reimbursement, Tolochenaz, Switzerland
  3. 3Medtronic, Clinical Bio Statistics, Minneapolis, USA
  4. 4Medtronic, Post Approval Clinical Surveillance, Maastricht, The Netherlands
  5. 5EHC Hôpital de Morges, Department of Anesthesia, Analgesia and Neuromodulation, Morges, Switzerland
  6. 6The James Cook Hospital, Department of Pain and Anaesthesia, Middlesbrough, UK
  7. 7Medtronic, Post Approval Clinical Surveillance, Minneapolis, USA


Background and aims Spinal cord stimulation (SCS) is an effective and well-established treatment for chronic intractable pain of the trunk and/or limbs. SCS is powered by an implantable pulse generator, which can be rechargeable or non-rechargeable primary cell (PC). For PC devices, battery life is an important factor from a clinical and cost perspective. The aim is to summarise the battery longevity of PCs in an international Product Surveillance Registry (PSR, Medtronic).

Methods The PSR is a prospective, long-term, multicentre global registry to monitor the performance and safety of Medtronic Spinal Cord Stimulation (SCS) systems.1 Battery longevity was analyzed using 1,983 PC devices in 1,699 patients at 66 sites with 3,531 device-years of follow-up. Statistical analysis was completed using Cox Proportional Hazard regression and Kaplan-Meier methods.

Results The median survival of PC devices was 49.9 months. Median survival was similar among CRPS, failed back pain, and other indications, 49.9 months, 49.2 months, and 49.9 months, respectively. Battery longevity using a survival plot for PC devices is displayed in figure 1. Median battery longevity for initial device implants was 55.7 months compared to 47.5 months for replacement devices. Stimulation setting for PC devices by initial implant or replacement are shown in table 1.

Conclusions The analysis demonstrated the expected performance of 49.9 months battery longevity for PC devices used in SCS therapy from real-world data. Battery longevity is impacted by programmed settings and patient usage, factors which should be considered when selecting battery type, owing to both the clinical and cost implications from a healthcare payer perspective.

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