FDAnews
www.fdanews.com/articles/172778-st-jude-medical-receives-ce-mark-approval-for-mri-conditional-labeling-of-prodigy-mri-chronic-pain-system

St. Jude Medical Receives CE Mark Approval for MRI Conditional Labeling of Prodigy MRI Chronic Pain System

August 25, 2015

St Jude Medical has received CE Mark approval for MRI conditional labelling of its Prodigy MRI chronic pain system with select leads. The launch will ensure patient access to the company’s proprietary Burst stimulation and traditional tonic stimulation.

The Prodigy MRI system will become the market’s smallest MR-conditional rechargeable implantable pulse generator, according to the company.

Octrode percutaneous and Penta 5-column paddle leads have received MR-conditional labeling and are approved for use with Prodigy MRI.

St. Jude Medical, based in St. Paul, Minn., develops solutions for patients to manage debilitating chronic pain, including spinal cord stimulation, targeted stimulation of the dorsal root ganglion and radiofrequency ablation. — Michael Cipriano