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

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.

KEYWORDS:

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

Article highlights

• BurstDR spinal cord stimulation is a unique energy delivery involving specific programming parameters and a passive recharge mechanism that mirrors the body’s natural electrical activity.

• The FDA recently approved the recharge-free Proclaim XR implantable pulse generator to provide BurstDR stimulation.

• There is substantial evidence to suggest low-dose BurstDR stimulation is more effective than higher dosages of the same stimulation pattern.

• When utilizing low-dose BurstDR stimulation, the Proclaim XR implantable pulse generator is expected to last 5–10 years without the need to recharge.

• The Proclaim XR is MRI conditional with specific imaging parameters that must be followed to ensure patient safety.

Declaration of interest

TR Deer is a consultant for Abbott, Vertos, Axonics, Flowonix, Saluda Medical, Vertos, SpineThera, Nalu, Cornerloc, SPR Therapeutics, and Vertiflex; is a member of the advisory board for Abbott, Flowonix, Nalu, SPR Therapeutics, and Vertiflex; has equity options in Bioness, Vertiflex, Axonics, Vertos, SpineThera, Saluda Medical, Nalu, and Cornerloc; is a research consultant for Abbott, Mainstay Medical, Saluda, SPR Therapeutics, and Vertiflex; and has a patent pending for the DRG paddle lead with Abbott. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This paper is not funded.