St. Jude Medical Gets FDA Approval For Proclaim Elite SCS System

(RTTNews) - Global medical device company St. Jude Medical, Inc. (STJ) Thursday said it received FDA approval for the new Proclaim Elite Spinal Cord Stimulation System. The device also got conditional magnetic resonance labeling that will allow patients to safely undergo head and extremity MRI scans.

The company said the Proclaim Elite SCS System is convenient to use and would offer relief and offers quality of life. This is claimed to be the first and only upgradeable and recharge-free spinal cord stimulation system available in U.S.

According to the Institute of Medicine, chronic pain affects more than 100 million Americans, an incidence rate which outpaces heart disease, cancer and diabetes combined.

St. Jude Medical said the current approval also includes the company's clinician programmer, which allows clinicians to program and adjust their patient's spinal cord stimulation therapy with an Apple iPad mini mobile digital device. Patients could evaluate spinal cord stimulation with the app based St. Jude Medical Invisible Trial System.