First Upgradeable Spinal Cord Stimulation System Receives FDA Approval

The U.S. Food and Drug Administration (FDA)has approved a new spinal cord stimulation device from St. Paul, Minn.-based St. Jude Medical Inc.

According to the company, the device—Protége IPG—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.

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 the device.

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, according to figures cited by St. Jude officials.

“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, 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.”

Until now, one of the greatest challenges with neurostimulation has been giving patients access to the latest technologies without surgically replacing their medical device.

St. Jude officials claim their new device is the world’s smallest neurostimulator to treat chronic pain of the trunk or limbs and pain from failed back surgery. It has a seven-year warranty and 10-year projected battery life.

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.

“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.”

Two clinical trials sponsored by St. Jude Medical that started in December 2013 are investigating alternative stimulation methods in spinal cord stimulation. (Read more here.)

Through an investigational device exemption (IDE) from the FDA, St. Jude Medical is evaluating whether a new waveform called burst stimulation can be more effective in managing chronic pain than traditional tonic stimulation. The purpose of the study, dubbed SUNBURST (Success Using Neuromodulation with BURST), is to evaluate the safety and efficacy of the Prodigy neurostimulator for the treatment of chronic intractable pain of the trunk and/or limbs. Prodigy is not approved for use in the U.S.

The SENSE (Subcutaneous and Epidural Neuromodulation System Evaluation) study is designed to evaluate the combination of peripheral nerve field stimulation and SCS to determine whether the two therapies together offer more effective management of chronic low back and leg pain than SCS alone.

Chronic pain affects approximately 1.5 billion people worldwide. In the United States, estimated costs include 515 million workdays lost and 40 million doctor visits annually. Today, patients around the world benefit from transformational pain management technologies from St. Jude Medical that enable them to return to work and live fuller, more satisfying lives. Patients can obtain more information about neurostimulation pain therapies at poweroveryourpain.com.

St. Jude Medical has four major clinical focus areas that include cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation.