St. Jude Introduces Prodigy Spinal Cord Stimulation System in Europe

St. Jude Medical said Thursday it has won European CE marking for its Prodigy chronic pain system with burst technology and is launching the product immediately in EU markets. 

The device combines traditional tonic spinal cord stimulation with burst technology that sends out an initial 40 Hz burst of stimulation, followed by five pulses at 500 Hz for 1 ms each. The combination provides an alternative therapy for patients with chronic pain in areas such as the lower back, St. Jude says. 

Prodigy consists of an implant with thin wires and electrodes that send low-level electrical signals to nerve fibers, masking or interrupting pain signals traveling to the brain. Its small size allows physicians to minimize incisions and select less visible implant locations, the company says. The system also includes an external, handheld device so that patients can adjust the amount of stimulation. It is compatible with the Prodigy Patient Programmer Model 3855 and the Rapid Programmer 3.5 Model 3835, spokeswoman Micki Sievwright told Device Daily Bulletin.

St. Jude is currently studying Prodigy through an investigational device exemption in the U.S., comparing traditional stimulation methods with burst stimulation for the treatment of chronic pain in patients 22 years and older. — Lena Freund

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