CE Marking for First MR-Conditional Rechargeable Spinal Cord Stimulator

A global medical device manufacturer has received CE (Conformité Européenne) approval for Magnetic Resonance Imaging (MRI) conditional labeling for its chronic pain system.

The approval enables patients to use the manufacturer’s Spinal Cord Stimulator (SCS) chronic pain products and Implantable Pulse Generator (IPG) and still have access to MRI exams.

The Prodigy MRI system, Octrode percutaneous and Penta 5-column paddle leads, manufactured by St. Jude Medical (St. Paul, MN) have all received MR-conditional labeling ensuring patients’ access to head and extremity MRI scans. St. Jude Medical also plans to ask for approval for full-body MR-conditional labeling in the future.

Chronic pain affects some 1.5 billion people around the world. In Europe 95 million people are affected, which costs the European health care systems EUR 300 billion every year. Until now, inaccessibility to MRI scans was a barrier for patients to benefit from SCS therapy.

Eric S. Fain, MD, group president of St. Jude Medical, 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. We want patients to have access to the most advanced therapies and technologies to effectively and safely reduce their chronic pain.”

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