Medtronic receives US FDA approval for Inceptiv closed-loop spinal cord stimulator

Medtronic plc announced that the U.S. Food and Drug Administration (FDA) approval for its Inceptiv closed-loop rechargeable spinal cord stimulator (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 the physician's prescribed stimulation, which is tailored to a patient's needs, in real-time, keeping therapy in harmony with the motions of daily life. Specialized circuitry and a proprietary algorithm detect ECAPs (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.

The Inceptiv system delivers additional advantages beyond its closed-loop capability. Inceptiv offers unparalleled access to diagnostic imaging, with 1.5T and 3T full-body MRI access with no power or impedance restrictions. It is the only FDA-approved closed-loop spinal cord stimulator that offers full-body 3T MRI access. It is the world's smallest and thinnest fully implantable SCS device, designed for patient comfort. In addition, Inceptiv SCS allows the option of multiple types of waveforms, including Medtronic's proprietary DTM SCS therapy, which demonstrated an 84% responder rate at 12 months in a large, multicenter randomized controlled trial (RCT). Patients with Inceptiv SCS can also access CareGuidePro, a mobile application and web portal that serves as a virtual guide throughout their Medtronic spinal cord stimulation therapy journey.

Medtronic will initiate the U.S. market launch of Inceptiv in the coming weeks. The system previously earned approvals for sale in Europe and Japan.