Medtronic's self-adjusting spinal cord stimulator snags European approval

Though standard spinal cord stimulation systems can be a major help in treating chronic pain, they may induce uncomfortable sensations themselves as users’ everyday movements cause them to shift positions.

Medtronic’s newest offering in the spinal cord stimulator space aims to ease that discomfort by automatically adjusting to those movements. The Inceptiv device has been designed as a closed-loop system, virtually eliminating the need for users to continually tweak their neurostimulation therapy based on their movements.

The spinal cord stimulator is set to begin rolling out in the European Union in the coming months, as Medtronic announced Friday that it has received CE mark approval. It hasn’t yet earned stateside approval from the FDA.

Spinal cord stimulators are implanted under the skin in the lower back, with leads placed in the epidural space around the spinal nerves. As an implanted patient coughs, sneezes, bends or stretches, those leads can move closer or farther away from the nerves than their original, ideal positioning, causing potentially uncomfortable changes in the amount of stimulation therapy the user feels.

Often, that discomfort will lead a patient to manually turn down the device’s therapeutic dosage—therefore disrupting their preset neurostimulation treatment plan.

Medtronic’s Inceptiv system, however, automatically responds to those movements itself. It senses the body’s neural response to the stimulation therapy 50 times per second, according to the company, so if it detects a change caused by a sneeze, for example, it can quickly reduce its output to avoid an uncomfortable spike in nerve stimulation. Then, as neural responses return to normal, so too does the device shift back to the prescribed output level.

Following a clinical study of the system, nine out of 10 participants reported a preference for the auto-adjusting closed-loop system compared to standard fixed-output stimulation, according to the devicemaker.

In Medtronic’s announcement, Ash Sharan, M.D., chief medical officer of the company’s neuromodulation business, said that the technology—and its newly bestowed European approval—mark “the beginning of a new era of pain relief, using sensing technology to listen to the unique biological signals of each patient.”

In addition to its auto-adjusting features, the Inceptiv system boasts what its maker claims is the thinnest-ever profile for a spinal cord stimulator, at a width of just six millimeters. It’s also rechargeable, with a full recharge reportedly taking only about an hour.

Finally, users implanted with the system are also safe to undergo MRI scans, which Medtronic says makes it the only spinal cord stimulation system in Europe to offer both full-body 1.5T and 3T MRI access—an important feature for those patients since, statistically, most of them will need an MRI within five years of being implanted with the device, according to Medtronic.