Health Canada Approves First Implant of St. Jude Medical’s Prodigy Chronic Pain System

Health Canada has approved the first implant in Canada of St. Jude Medical Inc.’s Prodigy chronic pain system with Burst technology. The Prodigy system is the only implantable spinal cord stimulation (SCS) system approved to deliver St. Jude Medical’s proprietary Burst stimulation as well as traditional SCS to reduce pain, improve patient satisfaction and eliminate paresthesia, the tingling sensation commonly associated with traditional SCS in some patients.

Burst stimulation is a form of neurostimulation therapy that delivers closely-spaced pulses of electrical energy to a patient’s spinal cord to manage chronic pain. According to St. Jude Medical, Burst stimulation may be a new option for patients whose pain is not adequately controlled, or for those who lose therapeutic benefit over time with tonic SCS alone. Early research reportedly indicates that burst stimulation may be able to deliver SCS therapy with little-to-no paresthesia and may be more effective than tonic stimulation, especially in managing complex back pain.

A 52-year-old man from Saskatoon received the Prodigy neurostimulator on May 13 due to his experience with chronic pain for several years following a successful trial experience and was performed by Ivar Mendez, M.D., Ph.D, FRCSC, FACS, from Saskatoon Health Region’s Royal University Hospital in Saskatchewan, Canada.

Chronic pain affects one in five adults in Canada and more than 1.5 billion people worldwide, more than heart disease, cancer and diabetes combined. The condition can negatively impact personal relationships, work productivity and a patient’s daily routine, and is a serious public health issue that remains largely under-treated and misunderstood.

“Burst stimulation is a novel technology for SCS that has the potential to be effective in patients that do not respond well to traditional tonic stimulation. Studies have shown that with Burst stimulation patients can experience reduced paresthesia and pay less attention to their pain improving their overall experience with SCS therapy,” said Mendez, who is chairman of the department of surgery at the University of Saskatchewan and the Saskatoon Health Region’s Royal University Hospital. “SCS therapy can provide significant pain relief and thus enable many patients to increase their activity levels and improve their overall quality of life. In combination with conventional tonic stimulation, Burst stimulation represents a comprehensive approach to effective pain management and allows me to tailor the therapy to my patient’s unique situation.”

SCS therapy uses an implanted pulse generator 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 the sensation of pain. Traditional tonic stimulation uses equally spaced electrical pulses to replace pain with a tingling sensation called paresthesia. For some patients, the stimulation sensation can fluctuate with changes in body position and paresthesia may become uncomfortable.

St. Jude Medical is a medical device company based in St. Paul, Minn.