St Jude Medical’s upgradable spinal cord stimulator gets FDA clearance

8 April 2014 (Last Updated April 8th, 2014 01:00)

St Jude Medical has obtained US Food and Drug Administration (FDA) approval for its Protégé IPG, an upgradeable neurostimulator designed to assuage chronic pain after traditional treatments have failed, by interfering with the transmission of pain signals using electrical pulses.

protege

St Jude Medical has obtained US Food and Drug Administration (FDA) approval for its Protégé IPG, an upgradeable neurostimulator designed to assuage chronic pain after traditional treatments have failed, by interfering with the transmission of pain signals using electrical pulses.

Protégé is claimed to be the first and only neurostimulation system that allows spinal cord stimulation (SCS) technology upgrades as they are approved to be made via software updates.

The upgrade feature provides chronic pain sufferers implanted with the Protégé access to therapies, stimulation modes, diagnostics or other features once approved through future software upgrades.

According to the company, chronic pain affects 100 million Americans and costs the US as much as $635bn each year.

In the US, estimated costs include 515 million workdays lost and 40 million doctor visits annually.

West Virginia's Center for Pain Relief president and CEO Dr Timothy Deer is an interventional pain physician and the first to implant a Protégé system

"This new device evolves with promising therapies," Dr Deer said. "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."

Protégé is claimed to be the world's smallest, longest-lasting rechargeable device to treat chronic pain. It has an unmatched seven-year warranty and offers industry-leading ten-year projected battery life. It also has open-ended device longevity without an automatic shutoff.

The Protégé neurostimulator is similar in function and appearance to cardiac pacemakers, which delivers mild electrical pulses to the spinal cord to mask or interrupt the pain signals' transmission to the brain.

"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."

St Jude Medical group president Dr Eric Fain said spinal cord stimulation therapy can transform the quality of life for patients who are otherwise unable to find relief from their chronic pain.

"Protégé allows patients the opportunity to benefit from future therapies and features even after they receive their implanted system," Dr Fain said.

"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."

Last month, the company launched Prodigy Spinal Cord Stimulation System with Burst Technology in Europe.

In addition, two clinical trials sponsored by St Jude Medical that started in December 2013 are currently investigating alternative stimulation methods in spinal cord stimulation.

St Jude Medical is currently 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.

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


Image: The Protege upgradeable neurostimulator. Photo: courtesy of St Jude Medical, Inc.