FDA Clears New Spinal Stimulation Device for Intractable Pain

Megan Brooks


September 18, 2017

The US Food and Drug Administration (FDA) has approved the Intellis spinal cord stimulation platform (Medtronic) for the management of chronic, intractable pain of the trunk and/or limbs associated with a variety of conditions, the company has announced.

The Intellis platform includes the world's smallest implantable spinal cord stimulator and offers personalized pain relief and advanced activity tracking, the company said in a news release.

The Intellis platform can help optimize treatment and improve patient-physician communication by tracking and sharing daily activities, body positions, and therapy usage and by giving physicians an objective look at mobility and progress, the company said.

"Chronic pain is challenging to manage. Having real-time data can provide more information about patients' quality-of-life changes. This platform represents a welcome new option for managing some kinds of chronic pain. New nonopioid treatment options are important, given the national crisis related to opioid abuse," Lance Roy, MD, pain medicine specialist at Duke University Medical Center, Durham, North Carolina, said in the release. One of the first implantation procedures in the United States using the Intellis platform was performed at Duke University Medical Center.

The Intellis platform was designed to overcome limitations with current spinal cord stimulation systems, such as battery performance. The platform uses Medtronic's proprietary overdrive battery technology. The battery can be fully recharged from empty to full in about 1 hour, and physicians can now estimate recharge intervals on the basis of therapy settings.

The platform also uses secure wireless clinician programmers managed on the Samsung Galaxy Tab S2 tablet interface that enable faster delivery of evolving workflows and software upgrades, the company said. The platform includes technology for automatic adjustments to deliver the right therapy dose to the right location, as the pain target shifts on the basis of body position.

Medtronic neurostimulation therapy for chronic intractable pain uses a medical device placed under a patient's skin to deliver mild electrical impulses through a lead implanted in the epidural space to block pain signals from going to the brain.

"Spinal cord stimulation [SCS] is a nonopioid therapy that is clinically proven and cost-effective for treating chronic pain. Multiple randomized controlled trials have demonstrated that SCS provides more effective pain relief than both reoperation and conventional medical management," Medtronic explained in a news release.

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