St. Jude Medical announced Monday that it is launching the world's first and only software upgradeable, nonrechargeable spinal cord stimulation system for chronic pain patients in Europe.

The Proclaim Elite Spinal Cord Stimulation System is also MR-conditional and can deliver both traditional spinal cord stimulation and burst stimulation. Burst stimulation is different from traditional or tonic stimulation in that the implantable device delivers closely spaced, high-frequency stimulation to the spinal cord and doesn’t result in the tingling sensation that patients feel during the traditional spinal cord stimulation process. Some chronic pain patients cannot tolerate traditional spinal cord stimulation because of the tingling sensation

By making the spinal cord stimulation system nonchargeable, the Minnesota device maker—the world's 14th largest by revenue—is making the device more consumer friendly. 

“We developed the Proclaim Elite SCS system to create a more patient-centric spinal cord stimulation therapy option,” said Allen Burton, M.D., medical director of neuromodulation and vice president of medical affairs at St. Jude Medical, in the news release. “With the launch of this device we are transforming the standard of care by packaging a series of important benefits into a single SCS device. The Proclaim Elite SCS system offers patients a combination of advanced pain therapy options and the convenience of a device that doesn’t require recharging, while removing barriers for future therapy and diagnostic options.”

Typically, St. Jude's rechargeable SCS system needs to be charged once a week, while other competing devices may need to be charged daily, according to a St. Jude Medical spokesman.

In another nod to the consumerization of healthcare, the novel device has software upgrade capability such that future enhancements will not require a surgical replacement of the implantable device. 

While the Proclain Elite SCS system with burst stimulation is available in Europe, in the U.S., burst stimulation is not yet available. Roughly two weeks ago FDA approved a version of the device that is nonrechargeable, upgradeable and MR-Conditional. St. Jude is currently studying burst stimulation through the SUNBURST U.S. clinical study, results of which will be presented at the North American Neuromodulation Society (NANS) in Las Vegas, Nevada, Dec. 10 - 13.  

Arundhati Parmar is senior editor at MD+DI. Reach her at [email protected] and on Twitter @aparmarbb

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