St. Jude Medical Wins FDA Approval for Spinal Cord Stimulation System
The FDA has granted approval to St. Jude Medical’s Proclaim Elite spinal cord stimulation system for people suffering from chronic pain.
The system enhances patient convenience, as it does not need to be regularly recharged, the St. Paul, Minn.-based devicemaker says. It also contains an upgradable platform that enables patients to access future upgrades, such as new stimulation waveforms.
The approval also includes conditional magnetic resonance labeling for the system, allowing patients to undergo head and extremity MRI scans.
It further covers St. Jude’s new clinician programmer, which allows for the use of an Apple iPad mini mobile digital device to program spinal cord stimulation therapy. — Michael Cipriano