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FDA OKs Upgradeable Spinal Cord Stimulation System

April 9, 2014

Patients implanted with St. Jude Medical’s Protégé upgradeable spinal cord stimulation system will be able to access device upgrades via software updates rather than replacement surgery, following the FDA’s green-lighting the system.

The system allows Protégé — which delivers mild electrical pulses to the spinal cord to interrupt or mask the transmission of pain signals to the brain — to access new therapies, new modes of stimulation, and diagnostics, among other features, the St. Paul, Minn., devicemaker said. The company hopes the capability will reduce subsequent surgeries and associated costs.

The device comes with a patient programmer that can be used at home to change stimulation options according to need, St. Jude spokesperson Micki Sievwright told Device Daily Bulletin. The implant and programmer communicate via radiofrequency.

Protégé is indicated for the management of chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome and intractable low-back and leg pain.

St. Jude also makes the Prodigy chronic pain system with Burst technology. The system was CE-marked last month, but is still investigational in the U.S., where it is being evaluated for safety and efficacy in treating chronic intractable pain of the trunk or limbs. — Lena Freund

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