St. Jude Medical’s Penta Lead Wins FDA Nod
St. Jude Medical’s Penta 5-column paddle lead for spinal cord stimulation has secured FDA 510(k) clearance, the St. Paul, Minn., company said Monday.
The lead is meant for use with the devicemaker’s Protégé MRI system, which generates electrical energy delivered via leads to nerve fibers along the spine, disrupting chronic pain signals as they travel to the brain, the company says. The system received FDA approval in April.
St. Jude Medical claims the Penta lead provides medical professionals with the broadest area of lateral stimulation coverage available, enabling the selective stimulation of nerve fibers.
About 1.5 billion people are afflicted with chronic pain worldwide, more than heart disease, cancer and diabetes combined, according to company estimates. — Jason Scott