Medtronic has received CE-mark approval for its Inceptiv closed-loop rechargeable spinal cord stimulator in the treatment of chronic pain.
Inceptiv is the first Medtronic spinal cord stimulation (SCS) device to offer a closed-loop feature that senses each person’s unique biological signals and adjusts stimulation moment to moment, as needed, to keep therapy in harmony with the motions of daily life.
Medtronic claims that—in contrast to more traditional, open-loop SCS technologies—Inceptiv is able 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 automatically decreases stimulation. As neural response decreases, stimulation returns to the pre-set optimal level. This is done “seamlessly” to provide consistent therapy while patients perform a full range of daily activities, according to a company press release.
“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 (University Hospital of Schleswig-Holstein, Lübeck, Germany). “This can compromise the patient’s experience and therapeutic effectiveness. The Inceptiv closed-loop feature will allow for a more consistent and optimal delivery of therapy, and reduced need for manual programming adjustments by the patient. Together with the compatibility of multiple types of waveform options, inclusive of DTM [differential target multiplexed] SCS, and industry-leading MRI [magnetic resonance imaging] access, I believe this latest generation of rechargeable neurostimulator represents a significant leap forward in SCS therapy and a milestone of modern neuromodulation.”
The Inceptiv device utilises a closed-loop capability with evoked compound action potentials (ECAPs)—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 the final report of the ECHO MAC clinical study, nine out of 10 patients preferred the optional closed-loop setting compared to fixed-output stimulation, Medtronic claims in its recent release.
The Inceptiv neurostimulator is “the only SCS system in Europe” offering both full-body 1.5T and 3T MRI access, the company also claims, and is “the thinnest SCS device in the world” at just 6mm. It offers the proven benefits of Medtronic’s proprietary DTM SCS therapy and the system’s battery can be recharged from empty to full in approximately one hour, the release further details.
The Inceptiv SCS system will be commercially available “in the coming months” in Europe, according to Medtronic, but is currently not approved for sale or distribution in the USA.