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St. Jude Medical obtains CE Mark for Prodigy chronic pain neurostimulator

St. Jude Medical has announced the CE Mark approval and launch of its Prodigy chronic pain system with Burst Technology in Europe.

It is designed to reduce pain, improve patient satisfaction and allow reduced paresthesia (a tingling sensation associated with 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 system features the longest-lasting battery life that requires recharging approximately once a week. Additionally, its small size allows for a smaller incision giving physicians increased flexibility in selecting the implant location and is intended to make the site less visible and more comfortable for patients.

Early evidence 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.

St. Jude Medical group president Dr Eric Fain said the Prodigy system is a great example of company’s 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.

"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," Dr Fain added.

Earlier in December 2013, the company 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 SUNBURST (Success Using Neuromodulation with BURST) trial is anticipated to enroll a maximum of 442 patients at up to 50 sites in the US.