St. Jude Medical (NYSE:STJ) said it’s putting its Prodigy neurostimulation device on the market in Europe for patients with chronic back pain after winning CE Mark approval.
St. Jude said the Prodigy device is designed to stimulate the spinal cord with low-level bursts of electricity to "interrupt or mask the transmission of pain signals to the brain" via both tonic and burst stimulation. The burst technology may help reduce a sensation of tingling along the spinal cord associated with tonic stimulation called paresthesia, according to a press release.
"Burst technology expands treatment options for patients suffering from chronic pain and provides significant relief so they can reclaim their quality of life," Dr. Dirk De Ridder of the University of Otago in Dunedin, New Zealand, said in prepared remarks. "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."
"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," added group president Dr. Eric Fain. "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."
Late last year St. Jude launched a U.S. clinical trial for the Prodigy device under an investigation device exemption for the chronic pain indication from the FDA. At the time the St. Paul, Minn.-based company said the Sunburst trial is slated to enroll a maximum of 442 patients at up to 50 sites in the U.S. The randomized 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, the company said.
