Medtronic announces approval of Inceptiv closed-loop rechargeable SCS by FDA

Medtronic announced that the FDA has approved the Inceptiv closed-loop rechargeable spinal cord stimulator, or SCS, for the treatment of chronic pain. Inceptiv is the first Medtronic SCS device to offer a closed-loop feature that senses biological signals along the spinal cord and automatically adjusts stimulation in real time, keeping therapy in harmony with the motions of daily life. Traditional fixed-output SCS devices deliver constant, mild electrical impulses that disrupt pain signals before they reach the brain. By contrast, Inceptiv SCS senses biological signals and consistently maintains the physician’s prescribed stimulation that is tailored to a patient’s needs. Specialized circuitry and a proprietary algorithm detect ECAPs, or Evoked Compound Action Potentials, signals generated by the spinal cord in response to electrical stimuli. ECAPs are a direct measure of how much nerve tissue is activated in the spinal cord and can be used to inform real-time adjustments to stimulation. Inceptiv SCS senses the body’s response to stimulation 50 times per second and instantly increases or decreases stimulation to maintain prescribed settings as determined by the physician.