Medtronic’s tiny neurostimulator gets CE mark for multiple indications

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Medtronic's Intellis system earned FDA clearance in September for spinal cord stimulation.

Medtronic’s Intellis platform grabbed a CE mark for peripheral nerve and spinal cord stimulation. With the nod, the device is now cleared to treat chronic, intractable pain of the trunk, posterior trunk and limbs.

The Intellis system, which earned the FDA green light in September, is the world’s smallest fully implantable spinal cord stimulation neurostimulator, the company said. The system includes the implant, a patient programmer and a recharger. A physician programs the therapy wirelessly, using a Samsung tablet.

The device is designed to help physicians make better treatment decisions. In addition to delivering pain-relieving neurostimulation, it records patient activity, such as their body position and how they self-administer their treatment, around the clock.


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"Rather than rely on patient-reported data, the enhanced activity tracker of the Intellis platform provides real-time data that offers more visibility into quality of life changes," said Jean-Pierre Van Buyten of AZ Nikolaas Hospital in Belgium, where the first European patient received the implant. "Better understanding a patient's experience can lead to a more informed conversation that can help me maximize their pain relief.”

Non-opioid pain treatments are becoming increasingly important—the number of opioids prescribed and sold in the U.S. alone has quadrupled since 1999. While opioids used to be prescribed sparingly—after a surgery or injury, or for managing cancer-related pain—there has been a “dramatic increase” in their use for chronic, non-cancer pain, according to the CDC.

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Some companies are developing painkilling drugs that do not have the same side effects as opioids, including dependence, constipation, nausea and sleepiness. On the device side, players like Medtronic and Abbott market neurostimulation treatments, with startups, such as SPR Therapeutics, trying to get a piece of the pie.

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