A Conformité Européene (CE) Mark has been received by Medtronic for its neurostimulation platform Intellis for spinal cord stimulation (SCS) and peripheral nerve stimulation (PNS) in the treatment of non-opioid chronic pain, including low back pain, allowing the device to be marketed in Europe.
Opioid abuse has reached critical levels globally, with US president Donald Trump last week declaring a ‘public health emergency’ for the crisis, paving the way for federal funds to be redirected into opioid research and non-opioid pain management.
Neurostimulation has shown positive results for managing chronic pain, with SCS providing ‘effective long-term pain relief’ in some patients, and PNS resulting in relief from back pain and improvement in pain-related disability. SCS therapy uses a neurostimulator implant to deliver mild electrical impulses to the epidural space, acting to block pain signals from reaching the brain. Differently, PNS neurostimulators deliver mild electrical signals directly to the nerves at the site of pain, with the aim of interrupting pain signals to the brain.
Chronic pain has been shown to affect all aspects of a person’s life, including relationships, mental health, work productivity, and daily living, with an estimated one-fifth of Western Europeans suffering from the debilitating condition.
Opioids, including extended release or long-acting (ER/LA) opioids such as morphine and methadone, and immediate release opioids such as fentanyl and oxycodone have long been used to treat chronic pain, including postoperatively, but the potential for misuse and addiction is high. A recent abstract, presented at the North American Spine Society (NASS) 2017 annual meeting showed that patients using opioids daily six weeks postoperatively were 6.9 times more likely to still be taking them daily two years after surgery (p<0.001).
The use of non-opioid treatments such as neurostimulators to manage pain is likely to decrease opioid use and dependence.
The Intellis system is “the world’s smallest fully implantable SCS neurostimulator,” says the Ireland-based Medtronic. “[It] simplifies and improves the patient experience with improved battery performance.”
Intellis is managed on an Android tablet interface, and tracks and records patient data 24 hours a day using the company’s Evolve workflow.
“Rather than rely on patient-reported data, the enhanced activity tracker of the Intellis platform provides real-time data that offers more visibility into quality of life changes,” says Jean-Pierre Van Buyten of AZ Nikolaas Hospital (Sint-Niklaas, Belgium).
Objective collection of patient data can assist in patient–doctor communication, enable better treatment plans, and improve pain relief.
“The launch of the Intellis platform is the culmination of 40 years of innovation,” says Marshall Stanton, senior vice president and president of Medtronic’s Pain Therapies division, adding that the technology is designed to optimise pain relief.
Neurostimulation is commonly prescribed and widely reimbursed in Europe, and current guidelines support the use of SCS. The primary indication for prescription of neurostimulation is after back surgery that does not lessen the patient’s pain (also known as failed back surgery syndrome).
The first European patient received surgery to implant the Intellis system at the Pain Clinic of AZ Nikolaas Hospital (Sint-Niklaas, Belgium), by Iris Smet, anaesthesiologist and neurosurgeon.
“Chronic pain is a complex disease that is challenging to manage. The innovations behind the Intellis platform translate into meaningful patient benefits and ease of use for physicians, which represent important advantages over other neurostimulators,” says Smet. “I want to restore my patient’s health and improve their quality of life; the innovation behind the Intellis platform allows me to achieve that and help a broad range of patients.”
Medtronic received marketing clearance in the USA by the Food and Drug Administration (FDA) in September.