Device profile of the Proclaim XR neurostimulation system for the treatment of chronic pain: an overview of its safety and efficacy

Jonathan M. Hagedorn, Alyson M. Engle, Priyanka Ghosh, Timothy R. Deer*

*Corresponding author for this work

Research output: Contribution to journalReview articlepeer-review

6 Scopus citations

Abstract

Introduction: Spinal cord stimulation is becoming an increasingly used modality for the treatment of chronic pain. The Proclaim XR implantable pulse generator (IPG) is a novel device designed to supply low-dose BurstDR stimulation in a primary cell battery guaranteed to last 5–10 years with appropriate programming. Areas covered: BurstDR stimulation involves specifically delivered pockets of electrical energy coupled with a passive recharge mechanism to mimic the body’s natural neuronal activity. MEDLINE databases were searched with a date range from 2010 to 2020, and a review of the evidence for low amplitude BurstDR stimulation, which led to FDA approval of the Proclaim XR system, is provided. In addition, we will review the safety and precautionary measures involved with this device. Expert opinion: The Proclaim XR IPG is the newest and most advanced device in SCS technology. It is designed to meet the preferences of patients by providing burst low amplitude intermittent dosing in a recharge-free manner and a guaranteed 5–10 year battery life.

Original languageEnglish (US)
Pages (from-to)499-505
Number of pages7
JournalExpert Review of Medical Devices
Volume17
Issue number6
DOIs
StatePublished - Jun 2 2020

Keywords

  • Chronic pain
  • device
  • neuromodulation
  • neurostimulation systems
  • spinal cord stimulation

ASJC Scopus subject areas

  • Surgery
  • Biomedical Engineering

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