St. Jude Medical (NYSE:STJ) said it launched a clinical trial of its Prodigy neurostimulator to examine the treatment of chronic pain.
The Sunburst trial, conducted under an investigational device exemption from the FDA, is slated to enroll a maximum of 442 patients at up to 50 sites in the U.S., St. Jude said. The randomized prospective trial 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 a press release.
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, according to the release. The burst technology may help reduce a sensation of tingling along the spinal cord associated with tonic stimulation called paresthesia, St. Jude said.
“The Prodigy spinal cord stimulation system with burst stimulation technology represents an important advancement in neurostimulation therapy,” chief medical officer Dr. Mark Carlson said in prepared remarks. “We are excited to be leading the effort through the Sunburst study to bring this novel stimulation mode to market, offering physicians a new alternative to manage patients suffering from severe chronic pain.”
“Severe chronic pain has a debilitating effect on patients’ lives,” added Dr. Timothy Deer, president & CEO of the Center for Pain Relief in Charleston, W. Va. “Burst stimulation may provide us with a comprehensive approach to managing patients whose pain is not adequately controlled with tonic spinal cord stimulation alone, or for those who lose therapeutic benefit over time. Importantly, we hope to demonstrate that burst stimulation produces paresthesia-free pain relief which may make it ideal for those who can’t tolerate traditional stimulation.”
