Medical device company Medtronic has secured the CE (Conformité Européenne) mark for its Inceptiv closed-loop rechargeable spinal cord stimulator (SCS) for the treatment of chronic pain.
Inceptiv, which delivers mild electrical impulses to the spinal cord, is said to be Medtronic’s first SCS device to offer a closed-loop function.
This technology detects each person’s own biological signals and modifies stimulation as necessary from moment to moment to keep therapy in sync with daily activities.
According to the company, Inceptiv SCS is designed to reduce mobility issues as it can sense the body’s neural response to stimulation 50 times per second, every second, every day.
The device automatically reduces stimulation when brain reaction spikes occur, for as when a patient coughs, sneezes, or bends.
The level of stimulation returns to the pre-determined ideal level when neuronal response declines, Medtronic said. The treatment is continuously provided in this way while patients doing their daily activities.
Medtronic Neuroscience Portfolio’s Neuromodulation chief medical officer Ash Sharan said: “Medtronic pioneered SCS for pain management more than 50 years ago, and we continue to deliver new innovations that personalise care and improve pain relief for patients.
“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.”
Available in the coming months in Europe, the Inceptiv neurostimulator has a closed-loop capability with ECAPs (Evoked Compound Action Potentials), which provides the ability to hear and react to signals along the spinal cord.
ECAPs are said to provide real-time information to enable the system to react to patient movements.
Inceptiv is also claimed to be the only SCS system in Europe that offers both full-body 1.5T and 3T MRI access. Its battery can also be recharged from empty to full in around one hour, the medical device company added.
Medtronic said that the neurostimulator is just 6mm in size, the thinnest SCS device in the world, and provides the benefits of the firm’s proprietary DTM spinal cord stimulation.