As government and healthcare professionals search for a solution to the opioid crisis, Medtronic has received FDA approval for the Intellis spinal cord stimulation platform to treat chronic, intractable pain of the trunk or limbs.
“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, which implanted one of the first Intellis units in a patient. “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.”
The Intellis platform was designed to overcome limitations with current spinal cord stimulation (SCS) systems, such as battery performance. It 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, Medtronic said.
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. 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, Medtronic said in a news release announcing the FDA approval.
“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. “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.”
“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.”
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. SCS is a non-opioid 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 re-operation and conventional medical management, Medtronic said.