FDA clears Medtronic's next-generation spinal cord stimulator

The FDA cleared Medtronic's latest spinal cord stimulation system for the treatment of chronic intractable pain. The world's smallest SCS, the Intellis device offers activity tracking and personalized pain relief. 

Designed to surmount limitations of current SCS devices, the Intellis platform comprises an implantable neurostimulator that records patient activity around the clock, a patient programmer and recharger. A physician manages the treatment on a Samsung tablet that allows the wireless programming of stimulation.

"We are excited to partner with Medtronic in their aim to simplify programming, and streamline therapy management with the Intellis platform," said Dr. Dave Rhew, chief medical officer and head of healthcare and fitness for Samsung Electronics America. "Samsung's Galaxy tablets-secured by the HIPAA-ready Samsung Knox mobile security platform-will support future Medtronic therapies and over the air (OTA) software upgrades to ensure clinicians using Intellis have access to the most up-to-date solutions." 

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The tracking includes daily activities, body positions and how patients self-administer their therapy, Medtronic said. Physicians may use this movement data to gauge how well a treatment program is working for each individual patient. Additionally, the Intellis stimulator is MRI-conditional, meaning that patients with the implant may undergo a diagnostic MRI on any part of the body under certain conditions. 

"Chronic pain is challenging to manage. Having real-time data can provide more information about patients' quality of life changes," said Dr. Lance Roy, a pain medicine specialist at Duke University Medical Center, in a statement. "This platform represents a welcome new option for managing some kinds of chronic pain. New non-opioid treatment options are important given the national crisis related to opioid abuse."