US-based medical technology developer St Jude Medical has started a clinical study of new Prodigy neurostimulator for assessing whether burst stimulation can be more effective in managing chronic pain than traditional tonic stimulation.
The SUNBURST (Success Using Neuromodulation with BURST) study is a randomised prospective trial that 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 Prodigy device is reportedly the first spinal cord stimulation (SCS) system 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 multi-centre trial, conducted under an investigational device exemption from the Food and Drug Administration (FDA), is expected to enroll a maximum of 442 patients at up to 50 sites in the US.
The Prodigy neurostimulator is a new investigational device with an expected ten-year battery life that requires recharging approximately once a week, and would be a major advance in neurostimulation technology that has not advanced much in 40 years.
The neurostimulation implant emits low levels of electricity through thin wires laid along the spinal cord to block or deaden pain signal transmissions to the brain.
A traditional spinal cord stimulation system leaves patients with a tingling sensation called paresthesia that burst stimulation may be able to reduce or even eliminate.
Center for Pain Relief president and CEO in Charleston West Virginia and interventional pain physician Dr Timothy Deer said severe chronic pain has a debilitating effect on patients’ lives.
"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," Dr Deer said.
"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."
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 chief medical officer and vice-president of global clinical affairs Dr Mark D Carlson said the Prodigy spinal cord stimulation system with burst stimulation technology represents an advancement in neurostimulation therapy.
"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," Dr Carlson said.
According to GlobalData estimates, the US spinal cord stimulators market was valued at $1.12bn in 2012 and is expected to grow at a CAGR of 9.2% to reach $2.08bn by 2019.
Image: Illustration of the Prodigy spinal cord stimulator being evaluated in the SUNBURST study. Photo: courtesy of St Jude Medical, Inc/BusinessWire.