FDA approves Proclaim™ XR SCS system for diabetic neuropathy

      The FDA approved Proclaim XR, a new implantable spinal cord stimulation device, as a treatment for pain from diabetes-related nerve damage. SCS systems, often referred to as neurostimulators, are fully implantable devices, implanted through an outpatient surgical procedure that deliver small vibrations or stimulations to the spine. This works to stop pain signals before they reach the brain, reducing the painful symptoms of neuropathy. The Proclaim XR SCS system can provide relief to DPN patients in need of alternatives to traditional treatment approaches, such as oral medication. People who receive therapy from the Proclaim XR SCS system will also be able to use Abbott's NeuroSphere™ Virtual Clinic, a connected care app that allows people to communicate with a physician and receive treatment adjustments remotely.