FDA Approval and U.S. Launch of Medtronic’s New Chronic Intractable Pain Platform

Medtronic plc has gained FDA approval and is now initiating the U.S. launch of its Intellis™ platform for the management of certain types of chronic intractable pain.

Background

Back problems are one of the top 10 most expensive medical conditions, with an estimated 30 percent of the 300,000 patients annually that undergo lumbosacral spine procedures developing chronic intractable pain. Chronic pain can negatively impact all aspects of a person’s life – relationships, work productivity and activities of daily living, yet it remains under-recognized and undertreated. Neurostimulation has been proven to provide effective long-term pain relief and improve quality of life, in addition to being a treatment option for patients interested in trying a non-drug alternative.

The Intellis platform was designed to overcome limitations with current spinal cord stimulation (SCS) systems, such as battery performance, and can power the EvolveSM workflow, which standardizes guidance and balances high-dose (HD) and low-dose (LD) therapy settings.

The Intellis platform can record and track patient activity 24/7 and is managed on the Samsung Galaxy Tab S2 tablet interface, enabling physicians to address the subjective and personal nature of chronic pain by monitoring progress and making modifications to better suit their patients’ therapy needs.

Physician comments

“Chronic pain is challenging to manage. Having real-time data can provide more information about patients’ quality of life changes,” said Dr. Lance Roy, pain medicine specialist at Duke University Medical Center. “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.”

Company comments

“Drawing upon our 40-year legacy in SCS, the launch of the Intellis platform isn’t just about a new device, but about combining cutting edge hardware with optimal therapy through the Evolve workflow to enable personalized, long-term pain relief,” said Marshall Stanton, M.D., senior vice president and president of Medtronic’s Pain Therapies division, which is part of the Restorative Therapies Group. “Medtronic is committed to addressing patient needs, so the Intellis platform was designed based on what is most important to patients and physicians. We considered the entire patient journey – starting with the primary goal of optimal pain relief and access to important diagnostic tools, like MRI, to ease of use with simplified programming, faster recharge and a smaller implant.”

Source: Medtronic plc

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