FDA approval for Inceptiv closed-loop spinal cord stimulator 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 stimulation in real time, keeping therapy in harmony with the motions of daily life.

"Pain is intensely personal, and stimulation therapy should meet the needs of every patient, moment to moment," said Dr. Krishnan Chakravarthy, M.D., Ph.D., Director of Innovative Pain Treatment Solutions and Surgery Center, VA San Diego Healthcare, and Chairman of the Empower You Chronic Pain Foundation. "Inceptiv listens to what the body is saying and, more quickly than you can blink, it seamlessly adjusts. This represents an important leap forward for the treatment of chronic pain."

Traditional fixed-output SCS devices deliver constant, mild electrical impulses that disrupt pain signals before they reach the brain. As patients go about their daily lives, certain movements such as laughing, bending, or sneezing may result in brief moments of uncomfortable overstimulation. This in turn may lead some patients to turn down their device's stimulation output, resulting in a suboptimal therapy experience.

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 (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. Up to 84% of SCS-implanted patients are expected to need at least one MRI within five years of implant. 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 in Japan.