St. Jude Medical has received the CE Mark approval for its Prodigy chronic pain system with Burst Technology and is now launching the system in Europe.
The next-generation neurostimulator is designed to reduce pain, improve patient satisfaction and reduce paresthesia (a tingling sensation associated with stimulation).
It is claimed to be the only implantable neuromodulation system that delivers burst stimulation.
In addition to Burst Technology for improved stimulation options, the new device offers patients traditional tonic spinal cord stimulation (SCS).
The Prodigy system can deliver both tonic and burst stimulation, which could address pain that is not fully managed by tonic stimulation alone. The system features the longest-lasting battery life to date, that requires recharging approximately once a week.
Additionally, the system’s compact size allows for a smaller incision, giving physicians increased flexibility in selecting the implant location and making the site less visible and more comfortable for patients.
University of Otago in Dunedin, New Zealand, neurological professor of neurosurgery Dr Dirk De Ridder said that Burst Technology expands treatment options for patients suffering from chronic pain and provides significant relief, so they can reclaim their quality of life.
"Prodigy’s pioneering stimulation mode allows me to tune therapy to my patient’s unique pain condition," Dr Ridder said.
"Burst holds the promise to fill the void where alternative stimulation modes fail to control patients’ pain or for those who lose therapeutic benefit over time."
Early research indicated 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, the company reported.
St. Jude Medical group president Dr Eric Fain said the Prodigy system is a great example of company’s approach to 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 the effect of therapy using traditional tonic stimulation.
"In addition to our recent investment in spinal modulation, the Prodigy neurostimulator showcases our continued commitment to expanding the neuromodulation programme for St. Jude Medical and focusing on improved outcomes for patients," Dr Fain said.
In 2013, St. Jude launched a US clinical trial for the Prodigy device under an investigation device exemption for the chronic pain indication from the FDA.
At the time, the company also said the success using neuromodulation with Burst (SUNBURST) trial is anticipated to enroll a maximum of 442 patients at up to 50 sites in the US.
The randomised prospective study will investigate whether the Prodigy device’s burst stimulation technology is safe and effective in treating chronic intractable pain, compared with traditional tonic stimulation.
According to GlobalData estimates, Europe spinal cord stimulators market was valued at $259.9m in 2012 and is expected to grow at an annual growth rate of 10.9%, to reach $535.8m by 2019.
Image: The Prodigy spinal cord stimulator obtains CE mark approval. Photo: courtesy of St. Jude Medical, Inc/BusinessWire.