FDA Approves 'Next-Generation' Spinal Cord Stimulator for Chronic Pain Management

Officials with the FDA have approved Medtronic's fully implantable spinal cord stimulation neurostimulator, Intellis. The Intellis platform can record and track patient activity all day and is managed on the Samsung Galaxy Tab S2 tablet interface, according to a press release from the company.¹

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. Researchers from Duke University Medical Center in Durham, N.C. implanted one of the first patients in the United States with the Intellis device.

The Intellis platform is designed to 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 Intellis platform also addresses a common patient complaint: battery recharge issues. With Medtronic's proprietary Overdrive(TM) battery technology, the Intellis battery can be fully recharged from empty to full in approximately 1 hour and physicians can now estimate recharge intervals based on therapy settings.

The Intellis platform also includes both Medtronic's proprietary SureScan(TM) MRI technology for the broadest access available to MRI diagnostic imaging and simple eligibility determination, which allows MRI scans anywhere on the body under certain conditions, as well as AdaptiveStim(TM) technology for automatic adjustments to deliver the right therapy dose to the right location, as the pain target shifts based on body position.

"Chronic pain is challenging to manage. Having real-time data can provide more information about patients' quality of life changes," said Lance Roy, pain medicine specialist at Duke University Medical Center said in the press release. "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."

Reference

1. Medtronic Announces FDA Approval and U.S. Launch of Next Generation Spinal Cord Stimulator for Chronic Pain Management [news release] Dublin. Medtronic website. http://newsroom.medtronic.com/phoenix.zhtml?c=251324&p=irol-newsArticle&ID=2301240. Accessed September 18, 2018.