St. Jude Medical Gets FDA Approval For MR-Conditional 5-Column Paddle Lead

(RTTNews) - St. Jude Medical Inc. (STJ) announced U.S. Food and Drug Administration approval of MR-conditional labeling for the company's Penta 5-column paddle lead for spinal cord stimulation or SCS therapy to manage chronic pain.

The Penta lead, which will be available for use with the company's Protégé MRI system in the U.S., is the only five-column paddle lead on the market that will allow patients to safely undergo head and extremity MRI scans.

For some chronic pain patients, the potential need for future MRI scans has historically acted as a barrier to SCS therapy. Throughout 2015, St. Jude Medical has introduced a series of MR-conditional implantable pulse generators (IPG's) and leads designed to improve patient access to the latest chronic pain therapy options while preserving the ability to undergo head and extremity MRI scans.

With the newly approved updated labeling, the Penta paddle lead will be available for use with the Protégé MRI system, which is the smallest upgradeable MR-conditional SCS IPG available in the U.S. In an SCS system, an IPG generates electrical energy, which is delivered via leads to nerve fibers along the spine to interrupt pain signals as they travel to the brain, reducing the sensation of pain.

The St. Jude Medical Penta paddle lead is designed to provide physicians the broadest area of lateral stimulation coverage available (9mm), which supports selective stimulation of nerve fibers associated with a patient's pain without needlessly stimulating other areas.

The company noted that the broad coverage of the Penta five-column paddle ensures sufficient stimulation when physicians are faced with anatomical asymmetries or in cases where stimulation is needed in very specific clusters of nerve fibers. Such specific targeting allows physicians to tailor therapy to a patient's unique pain pattern.