“New” Recharge-Free Spinal Cord Stimulator for Chronic Pain Gets FDA Nod

A “new” recharge-free and upgradeable spinal cord stimulation (SCS) system for the treatment of chronic pain gained FDA approval this week.

The device, made by St. Jude Medical, is being billed as the “first and only” such system available to pain sufferers in the US.

With respect to “upgradeability”, the company stated, “The system’s upgradable platform allows patients to access future SCS technology upgrades, such as new stimulation waveforms and software updates, without surgical device replacement. Historically, most patients would need additional surgery to receive product upgrades as they are approved.”

The company’s statement did not clarify if this upgradeability was unique to the system, or if simply most patients historically attained new technology through re-implantation because recharge-free batteries used to require surgical replacement every few years when the battery died.

Regarding “recharge-free” benefits, the company stated, “The non-rechargeable system improves patient convenience by removing the burden of regularly recharging the SCS system.”

Interestingly, for decades the only type of SCS systems were recharge-free, and there were inherent problems with these systems, the main one being that the batteries would typically die within a few short years (sometimes less than 18 months) before needing surgical replacement.

In 2008, the first rechargeable spinal cord stimulation system was approved by the FDA and was considered a major breakthrough because the implanted batteries would last a decade or more than non-rechargeable ones. In addition, the amount of power available to deliver precise stimulation through rechargeable power was considered therapeutically beneficial.

That first rechargeable neuromodulation system was made by St. Jude competitor, Boston Scientific. Not long after, both St. Jude and Medtronic also developed rechargeable SCS systems, which set the technology tone for the last seven years.

So, why change back to the past?

According to the company’s press release, “the non-rechargeable system improves patient convenience by removing the burden of regularly recharging the SCS system.”

That inconvenience was more than a burden for a few patients, who in the early years of using rechargeable SCS systems were burned on the skin after recharging in a non-compliant way, such as falling asleep on top of the charging system. Those issues were later managed with safety controls.

“The approval of the Proclaim Elite recharge-free SCS system is a needed advancement for both patients and physicians who now have access to a low-maintenance chronic pain treatment that can reduce interference with daily activities,” said Timothy R Deer, M.D., president and chief executive officer of The Center for Pain Relief in Charleston, West Virginia.

While this “needed advancement” comes from the past, the real question is, will this recharge-free system last long enough before it needs to be surgically replaced when the battery dies to offset the inconvenience of charging up the battery?

The FDA approval also included conditional magnetic resonance (MR) labeling for the Proclaim Elite SCS system, which will allow patients to safely undergo head and extremity MRI scans.

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