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St. Jude Medical receives CE mark approval for MRI conditional labelling of Prodigy system

Medical device firm St. Jude Medical has received CE mark approval for magnetic resonance imaging (MRI) conditional labelling of the Prodigy MRI chronic pain system with select leads.

St Jude

The Prodigy MRI system is claimed to be the market’s smallest MR-conditional rechargeable implantable pulse generator (IPG), as well as industry’s sole MR-conditional SCS system that can deliver the firm’s proprietary Burst stimulation and traditional tonic stimulation.

Burst stimulation is a proprietary neurostimulation waveform, which functions independently from stimulation cycles and programming compared to other SCS systems, according to the company.

St. Jude Medical group president Dr Eric Fain said: "MRI compatibility in our Prodigy system answers a growing market demand for devices that enhance patient access to new stimulation modes and therapy options.

"MRI compatibility for head and extremity will reduce treatment limitations or restrictions for chronic pain patients who may have future MRI needs."

All Octrode percutaneous and Penta 5-column paddle leads have received MR-conditional labelling and are approved for use with Prodigy MRI, in addition to the approval of Prodigy MRI.

The company is also planning to get approval for updated labeling in key markets across the globe for additional chronic pain products and intends to submit testing data to support full-body MR-conditional labeling for their future SCS systems.

The company offers multiple solutions for patients to manage debilitating chronic pain, including spinal cord stimulation, targeted stimulation of the dorsal root ganglion (DRG) and radiofrequency ablation (RFA).


Image: St. Jude Medical’s global headquarters. Photo: courtesy of St. Jude Medical, Inc.