St. Jude Medical Initiates Prodigy Neurostimulator Clinical Study - Quick Facts

(RTTNews) - St. Jude Medical, Inc. (STJ) said Tuesday that it has initiated a clinical study of the Prodigy neurostimulator, the first spinal cord stimulation or SCS system able to deliver a proprietary mode of stimulation therapy called burst stimulation.

The company noted that SUNBURST or Success Using Neuromodulation with BURST study will evaluate whether burst stimulation can be more effective in managing chronic pain than traditional tonic stimulation.

The firm stated that the Spinal cord stimulation is a proven therapy that has been used to manage chronic pain for more than 40 years. The procedure involves the implant of a small neurostimulation device that powers thin wires placed along the spinal cord. The device emits low levels of electrical energy to interrupt or mask the transmission of pain signals to the brain. Patients with a traditional SCS system feel the mild pulses of energy as a tingling sensation called paresthesia.

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 said.

The SUNBURST study is a randomized, prospective, multicenter, clinical study designed to demonstrate the safety and efficacy of the Prodigy neurostimulation system using tonic and burst stimulation therapy to manage patients with chronic intractable pain. A maximum of 442 patients will be enrolled at up to 50 sites in the U.S.

The Prodigy neurostimulator is a new investigational device with an expected 10-year battery life that requires recharging approximately once a week. The neurostimulator is designed to deliver both tonic and burst stimulation which may be able to address pain not fully managed by tonic stimulation alone.