Regulatory Self-adjusting spinal cord stimulator from Medtronic receives European clearance

Self-adjusting spinal cord stimulator from Medtronic receives European clearance

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While traditional systems for spinal cord stimulation play a significant role in managing chronic pain, they can inadvertently lead to uncomfortable sensations as the wearer’s everyday movements prompt shifts in their position. Medtronic, a leading medical technology company, aims to address this issue with its latest innovation in spinal cord stimulation technology – the Inceptiv device. This cutting-edge device operates as a closed-loop system, mitigating users’ need for constant adjustments to their neurostimulation therapy based on movement.

The Inceptiv spinal cord stimulator is poised to make its debut in the European Union in the forthcoming months, following Medtronic’s announcement of receiving the CE mark approval. However, approval from the FDA in the United States is still pending.

In the procedure, spinal cord stimulators are surgically implanted beneath the skin in the lower back, with leads carefully placed in the epidural space around the spinal nerves. Unfortunately, a person’s natural movements, such as coughing, sneezing, bending, or stretching, can cause these leads to shift from their ideal positions. Consequently, this movement can lead to unwelcome changes in the amount of stimulation therapy received, prompting discomfort. In many cases, patients resort to manually reducing the therapeutic dosage, thereby disrupting their predetermined neurostimulation treatment plan.

Medtronic’s Inceptiv system offers an innovative solution by autonomously responding to these movements. The system’s responsiveness is impressive, as it monitors the body’s neural reactions to stimulation therapy at 50 times per second. This means that if a movement like sneezing is detected, the device can swiftly adjust its output to prevent an abrupt and uncomfortable surge in nerve stimulation. As the body’s neural responses normalize, the device returns to its prescribed output level.

Based on the outcomes of a clinical study, the Inceptiv system received positive feedback. Approximately 90% of participants expressed a preference for the auto-adjusting closed-loop system over the traditional fixed-output stimulation methods, according to Medtronic.

Dr. Ash Sharan, the Chief Medical Officer of Medtronic’s neuromodulation business, highlighted the significance of this technology and its European approval. He noted that this development marks the commencement of a new era in pain relief, utilizing sensing technology to attune to the distinctive biological signals of each individual.

Beyond its auto-adjusting capabilities, the Inceptiv system boasts an ultra-slim profile claimed to be the slimmest for a spinal cord stimulator, measuring just six millimeters in width. Moreover, it features a rechargeable design, allowing a full recharge in approximately one hour.

An additional advantage of the Inceptiv system is its compatibility with MRI scans. Medtronic asserts that it is the sole spinal cord stimulation system in Europe that offers access to both full-body 1.5T and 3T MRI scans. This attribute holds particular importance for patients, as statistical data indicates that a majority of them will require an MRI within five years of the device implantation.

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