St. Jude Medical, Inc., a global medical device company, today 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 paresthesia (a tingling sensation associated with stimulation). The new device offers patients traditional tonic spinal cord stimulation (SCS) 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,” 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.” SCS (also known as neurostimulation) therapy uses an implanted device, similar to a cardiac pacemaker, and thin wires with electrodes to deliver low levels of electrical energy to nerve fibers. These electrical pulses mask or interrupt pain signals as they travel to the brain, reducing painful sensations. Traditional stimulation uses equally spaced electrical pulses to replace pain with a tingling sensation called paresthesia. For some patients, the stimulation sensation can fluctuate and paresthesia may become uncomfortable. For others, traditional stimulation does not effectively relieve their pain.
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 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.
Chronic pain affects one in five adults across Europe and more than 1.5 billion people worldwide. It is a serious public health issue that remains largely under-treated and misunderstood.
“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.” The Prodigy system features the longest-lasting battery life, even at the highest settings, of any rechargeable SCS 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 (IDE) from the U.S. 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 U.S.