St. Jude Claims “World First” as FDA Approves Upgradeable Spinal Cord Stimulator

St. Jude Medical, Inc., is trumpeting the U.S. FDA approval of its Protégé™ IPG. Protégé is the first and only neurostimulation system that allows spinal cord stimulation (SCS) technology upgrades as they are approved to be made via software updates.

Background

SCS is a proven therapy that has been used to help manage chronic pain and improve patients’ quality of life. Until now though, one of the greatest challenges with neurostimulation has been giving patients access to the latest technologies without surgically replacing their implant.

Now though, chronic pain sufferers implanted with the newly approved Protégé™ IPG device can relax in the knowledge that they won’t need to have it replaced in order to receive innovative therapies, stimulation modes, diagnostics or other features once approved, through future software upgrades.

Spinal cord stimulation is an important therapy option for patients who have not been able to alleviate their chronic pain through traditional methods. Similar in function and appearance to a cardiac pacemaker, the Protégé neurostimulator delivers mild electrical pulses to the spinal cord, which interrupt or mask the pain signals’ transmission to the brain.

St. Jude tells us 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.

Eighty-eight percent of patients report satisfaction at two years post-implant with a St. Jude Medical neurostimulator, saying their quality of life has been greatly improved.

Physician comments

“In the first 40 years of SCS we’ve seen advances in hardware but limited progress in software and programming. This new device evolves with promising therapies,” said Dr. Timothy Deer , an interventional pain physician, president and CEO of the Center for Pain Relief in Charleston, W. Va., and president-elect of the International Neuromodulation Society, who was the first physician to implant a Protégé system. “With its upgradeability, SCS 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.”

Company comments

“Spinal cord stimulation therapy can transform the quality of life for patients who are otherwise unable to find relief from their chronic pain,” said Eric S. Fain , M.D., group president of St. Jude Medical. “Protégé allows patients the opportunity to benefit from future therapies and features even after they receive their implanted system. This draws upon St. Jude Medical’s promise to the quality and durability of its products and our commitment to continuously innovating in the neuromodulation space.”

Source: St. Jude Medical, Inc., Business Wire

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