Prodigy spinal cord stimulation system gets CE mark approval

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St Jude Medical announced the CE mark approval and European launch of its Prodigy chronic pain system with burst technology. As the first and only implantable neuromodulation system that delivers burst stimulation, the Prodigy system is designed to reduce pain, improve patient satisfaction and allow reduced paraesthesia. The new device offers patients traditional tonic spinal cord stimulation in addition to burst technology for improved stimulation options.

“Burst technology expands treatment options for patients suffering from chronic pain and provides significant relief so they can reclaim their quality of life,” says 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.”

 

 


St Jude Medical’s new burst technology offers intermittent “bursts” of stimulation designed to provide an alternative therapy method for chronic conditions such as back pain. In addition, burst stimulation has been demonstrated to minimise paraesthesia 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 Prodigy system features the longest-lasting battery life, even at the highest settings, of any rechargeable spinal cord stimulation device in its class. Additionally, its small size allows for a smaller incision, which gives physicians increased flexibility in selecting the implant location and is intended to make the site less visible and more comfortable for patients.

 


Through an Investigational Device Exemption from the US Food and Drug Administration (FDA), the 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. The Prodigy neurostimulator is not approved for use in the USA.