Cardiac technology developer St. Jude Medical has received U.S. Food and Drug Administration (FDA) approval of MR-conditional labeling for its spinal cord stimulation paddle lead.
The firm's Penta five-column paddle lead for spinal cord stimulation therapy to manage chronic pain will be available for use with the Protégé MRI device. The unit is an upgradeable MR-conditional spinal cord stimulation implantable pulse generator, according to St. Jude.
The Penta paddle lead is designed to provide a broad area of lateral stimulation coverage (9 mm), which supports selective stimulation of nerve fibers associated with a patient's pain without stimulating other areas. The broad coverage of the paddle ensures stimulation when physicians are faced with anatomical asymmetries or in cases where stimulation is needed in very specific clusters of nerve fibers, St. Jude said.
