St. Jude Gains FDA Approval for Upgradeable Neurostimulation Device

Protégé, which St. Jude Medical is billing as “the world’s first and only upgradeable spinal cord stimulation system,” has been granted premarket approval from the U.S. Food and Drug Administration (FDA). Protégé is a neurostimulation system that allows spinal cord stimulation (SCS) technology upgrades to be made via software updates as they are approved. Chronic pain sufferers implanted with this new device can access therapies, stimulation modes, diagnostics or other features once approved through future software upgrades, without the need to surgically replace their medical device. It is designed to treat chronic pain of the trunk or limbs and pain from failed back surgery.

Chronic pain affects 100 million Americans, more than heart disease, cancer and diabetes combined. The debilitating disease is cause for 40 percent of work absences due to back pain, second only to the common cold (50 percent), and costs the nation more than $635 billion each year in medical treatment and lost productivity. SCS is a proven therapy that has been used to help manage chronic pain and improve patients’ quality of life.

“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 Timothy Deer, M.D., 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, and 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.”

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

St. Jude is offering a seven-year warranty for the device, which has a reported 10-year projected battery life. Protégé 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.

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 claims.

“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.”

St. Jude’s Protégé neurostimulator and Prodigy Chronic Pain System with Burst Technology recently earned European approval. Additionally, the company is sponsoring two clinical trials that started in December 2013 that are investigating alternative stimulation methods in spinal cord stimulation.

St. Jude medical is a medical device company based in St. Paul, Minn.