FDA approval for world’s first upgradeable spinal cord stimulation system


St Jude Medical announced the approval of its Protégé IPG from the US Food and Drug Administration (FDA). Protégé is the first and only neurostimulation system that allows spinal cord stimulation technology upgrades as they are approved to be made via software updates. Chronic pain sufferers implanted with this new device can access innovative therapies, stimulation modes, diagnostics or other features once approved through future software upgrades — without the need to surgically replace their medical device.

“In the first 40 years of spinal cord stimulation we’ve seen advances in hardware but limited progress in software and programming. This new device evolves with promising therapies,” says Timothy Deer, an interventional pain physician, president and chief executive officer of the Center for Pain Relief in Charleston, USA, and president-elect of the International Neuromodulation Society, who was the first physician to implant a Protégé system. “With its upgradeability, spinal cord stimulation patients can readily access newly approved stimulation methods, allowing the latest technology to be synced with their medical device. This will reduce additional surgeries and lower the cost of care.”


Until now, one of the greatest challenges with neurostimulation has been giving patients access to the latest technologies without surgically replacing their medical device. According to St Jude Medical, Protégé changes the standard for spinal cord stimulation, allowing patients to access future innovations and therapies once approved without the cost and risks associated with surgical replacement.


Protégé is the world’s smallest neurostimulator to treat chronic pain of the trunk or limbs and pain from failed back surgery. It has an unmatched seven-year warranty and offers industry-leading 10-year projected battery life. It also has open-ended device longevity without an automatic shutoff. Protégé is built on a solid platform of success: 88% of patients report satisfaction at two years post-implant with a St Jude Medical neurostimulator, saying their quality of life has been greatly improved.