Medtronic Is Closing the Loop on Spinal Cord Stimulation

Medtronic has received a CE mark for its Inceptiv closed-loop rechargeable spinal cord stimulator (SCS). It is the first Medtronic SCS device to offer a closed-loop feature designed to sense each patient's unique biological signals and adjust spinal cord stimulation moment to moment, as needed.

"Inceptiv incorporates closed-loop therapy with ECAPs [evoked compound action potentials], the result of decades of Medtronic R&D, to unlock the ability to listen and respond to signals along the spinal cord," Medtronic CEO Geoff Martha said during the company's fiscal Q1 2024 earnings call last month.

Spinal cord stimulation devices deliver mild electrical impulses to the spinal cord, which can disrupt pain signals before they reach the brain. As patients go about their daily lives, certain movements may result in uncomfortable stimulation. This in turn may lead some patients to turn down their device's stimulation output, resulting in suboptimal therapy experience.

By contrast, Medtronic said the Inceptiv device is designed to sense the body's neural response to stimulation 50 times per second, every second of every day. When neural response increases, such as when the patient coughs, sneezes, or bends, Inceptiv is designed to automatically decrease stimulation. As neural response decreases, stimulation returns to the pre-set optimal level. According to Medtronic, this is done seamlessly to provide consistent therapy while patients perform a full range of daily activities.

"Today, fixed-output spinal cord stimulation does not account for patient movements, which can alter the distance between the spinal cord and implanted epidural leads," said Dirk Rasche, MD, from the Department of Neurosurgery, University Hospital of Schleswig-Holstein in Lübeck, Germany. "This can compromise the patient´s experience and therapeutic effectiveness."

Rasche said this latest generation of rechargeable neurostimulator represents a significant leap forward in spinal cord stimulation therapy and a milestone of modern neuromodulation.

ECAPs are a direct measure of how much neural tissue is activated in the spinal cord in response to electrical stimuli, providing real-time information that enables the system to respond to patient movements. In a clinical study, nine out of 10 patients preferred the optional closed-loop setting compared to fixed-output spinal cord stimulation, according to the company.

"This approval marks the beginning of a new era of pain relief, using sensing technology to listen to the unique biological signals of each patient," said Ash Sharan, MD, chief medical officer of neuromodulation at Medtronic.

According to Medtronic, the Inceptiv neurostimulator is the only SCS system in Europe offering both full-body 1.5T and 3T MRI access. Most people with SCS will need an MRI within five years of receiving their device, the company noted. Inceptiv is also the thinnest SCS device in the world at just 6mm, Medtronic touted. The system's battery can be recharged from empty to full in about one hour.

The Inceptiv SCS system will be commercially available in the coming months in Europe but is not approved for sale or distribution in the United States.