Medtronic’s Inceptiv Closed-Loop, Rechargeable Spinal Cord Stimulator Gets FDA Approval

Medtronic has earned U.S. Food and Drug Administration (FDA) approval for its Inceptiv closed-loop, rechargeable spinal cord stimulator (SCS) to treat chronic pain.
 
Inceptiv, according to Medtronic, it is first SCS device with a closed-loop feature that senses biological signals in the spinal cord and adjusts stimulation in real-time. This keeps therapy aligned to the motions of the patient’s daily life.
 
Fixed-output SCS devices use constant, mild electrical impulses that stop pain signals before they reach the brain. However, movements like laughing, bending, or sneezing can cause short instances of uncomfortable overstimulation—leading some patients to reduce their device’s stimulation output.
 
Inceptiv’s specialized circuitry and proprietary algorithm detect ECAPs (evoked compound action potentials), which are signals the spinal cord generates in response to electrical stimuli. They’re a measure of how much nerve tissue is activated in the spinal cord and can be leveraged to inform real-time stimulation adjustments.
 
According to Medtronic, the Inceptiv SCS senses response to stimulation 50 times a second, instantly raising or lowering stimulation to maintain physician-prescribed settings. It’s also the only FDA-approved closed loop SCS that allows full-body 3T MRI scans and the smallest and thinnest fully implantable SCS device.
 
Inceptiv employs Medtronic’s proprietary DTM SCS therapy. The company plans to begin U.S. market launch in the coming weeks—it’s already been approved for sale in Europe and Japan.
 
“A new era for spinal cord stimulation technology is beginning, and with Inceptiv SCS, Medtronic is at the forefront,” said David Carr, VP and GM of Medtronic’s Pain Interventions business. “For patients dealing with chronic pain, every day is a struggle. They deserve personalized and effective relief, without compromising future access to MRI. They deserve the comfort that the smallest and thinnest device on the market can provide. We are proud to offer the most cutting-edge solution available today with Inceptiv SCS.”