The unit is a small MR-conditional rechargeable implantable pulse generator, the company said. The spinal cord stimulation system is capable of delivering both St. Jude Medical's proprietary Burst stimulation and traditional tonic stimulation.
In addition to the approval of Prodigy MRI, all of the company's Octrode percutaneous and Penta five-column paddle leads have received MR-conditional labeling and are approved for use with Prodigy MRI. The Penta lead offers lateral coverage to control current and stimulate spinal nerves based specifically on patient need.
St. Jude Medical has also announced plans to seek updated labeling in markets around the world for additional chronic pain products, and it plans to submit testing data to support full-body MRI-conditional labeling for future spinal cord stimulation systems.
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