A spinal cord stimulator uses mild electrical pulses to disrupt pain signals as they travel through the nervous system before they reach the brain. Credit: Shutterstock / Ljupco Smokovski.

Medtronic secured approval from the US Food and Drug Administration (FDA) for its closed-loop spinal cord stimulation (SCS) device, designed to adjust stimulation in real-time, for the treatment of chronic pain.

According to Medtronic, Inceptiv is the first spinal cord stimulation device to offer a closed-loop feature that can sense biological signals across a patient’s spine, adjusting the output of the electrical pulses used to stimulate the spine in rhythm with the user.

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A spinal cord stimulator uses mild electrical pulses to disrupt pain signals as they travel through the nervous system before they reach the brain. In a traditional version of the device, the output of the stimulator is set manually by the user, but Medtronic’s Inceptiv device detects user movements and signals to adjust its output to match a strength selected by the user’s doctor.

David Carr, vice president of Medtronic’s pain modulation arm, said: “For patients dealing with chronic pain, every day is a struggle. They deserve personalised 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.”

Research by GlobalData estimates that the overall market for neuromodulation devices such as SCS devices is predicted to reach a market value of $10.7bn in 2030, up from $9bn in 2023.

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In addition, Medtronic has said the device comes with the bonus of offering access to diagnostic imaging, with the ability to use 1.5T and 3T full-body MRI with no power or impedance restrictions. Research carried out by the US National Institute of Health found that approximately 84% of people implanted with a SCS device are likely to need an MRI scan within five years of getting the implant.

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Previously, Medtronic was able to demonstrate that its SCS technology was able to significantly decrease pain in those suffering from chronic back conditions as part of a 12-month study, which saw Medtronic’s differential target multiplexed (DTM) outpacing traditional spinal cord stimulators.

The US approval follows market clearances for Inceptiv in both the EU and Japan. Elsewhere in the field of spinal cord stimulation, the US-based XStim has similarly received premarket approval from the FDA for its own Xstim spine fusion stimulator, aimed at treating patients recovering from spinal fusion therapy.