CE Mark and EU Launch for St. Jude’s Prodigy Spinal Cord Stimulation System with Burst Technology

St. Jude Medical, Inc. has seen its Prodigy™ Chronic Pain System with Burst Technology gain CE Mark approval, which it says will be followed by European launch.

Background

Spinal Cord Stimulation has been used for more than 40 years to help manage chronic pain and improve patients’ quality of life. Neurostimulators are similar in function and appearance to cardiac pacemakers, delivering mild electrical pulses to the spinal cord, which interrupt or mask the pain signals’ transmission to the brain.

St. Jude Medical’s Prodigy system is the first and only implantable neuromodulation system that has the added feature known as “burst stimulation”. This means it delivers intermittent “bursts” designed to provide an alternative therapy method for chronic conditions such as back pain. In addition, burst stimulation has been demonstrated to minimize paresthesia in some patients which can often fluctuate with posture and body position changes. Early evidence suggests that by enabling the delivery of both modes of stimulation, clinicians can more effectively adjust therapy to address the patient’s unique pain condition.

The new device offers patients traditional tonic spinal cord stimulation (SCS) in addition to Burst Technology for improved stimulation options.

Through an Investigational Device Exemption from the U.S. FDA, a St. Jude Medical study called SUNBURST™ (Success Using Neuromodulation with BURST) is evaluating whether burst stimulation can be more effective in managing chronic pain than traditional tonic stimulation. In the meantime the Prodigy neurostimulator is not approved for use in the U.S.

Physician comments

“Burst Technology expands treatment options for patients suffering from chronic pain and provides significant relief so they can reclaim their quality of life,” said Dr. Dirk De Ridder, Neurological Professor of Neurosurgery, from the University of Otago in Dunedin, New Zealand. “Prodigy’s pioneering stimulation mode allows me to tune therapy to my patient’s unique pain condition. Burst holds promise to fill the void where alternative stimulation modes fail to control patients’ pain or for those who lose therapeutic benefit over time.”

Company comments

“The Prodigy system is a great example of our approach for innovative and alternative ways to provide relief to patients suffering from chronic pain, including those who have exhausted other treatment options or who may have lost effective therapy using traditional tonic stimulation,” said Eric S. Fain, M.D., group president of St. Jude Medical. “In addition to our recent investment in Spinal Modulation, the Prodigy neurostimulator showcases our continued commitment to expanding the neuromodulation program for St. Jude Medical and focusing on improved outcomes for patients.”

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

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