The medical device company Medtronic, Inc. (NYSE: MDT) has introduced in Europe the first line of spinal cord stimulators that are compatible with magnetic resonance imaging (MRI) for the treatment of chronic back pain and leg pain. Medtronic recently received Conformité Européenne (CE) Mark approval for devices with full-body MRI scans.
“Neurostimulation therapy has become a mainstay of chronic pain management, and the introduction of full-body, MRI-compatible spinal cord stimulation systems is an important advancement that will help ensure neurostimulation patients have access to the diagnostic tools needed to quickly identify potentially critical health conditions,” said Dr. JP Van Buyten from Belgium’s AZ Niklaas Hospital.
Medtronic has applied for, but has not yet received permission from the Food and Drug Administration to use the devices in the U.S.
Spinal cord stimulators implanted in the spine as part of neurostimulation therapy can offer significant relief to patients with chronic pain, but they often impede disease diagnoses because they render full-body MRI scans unsafe. That is because stimulators could be damaged by the magnets used in an MRI scan.
An MRI scan uses radio frequency pulses and magnetic fields to construct images of structures inside the body. MRI scans are an important diagnostic tool for physicians to view a highly detailed image of joints, muscles, blood vessels, tumors, internal organs, and more. Worldwide, approximately 60 million MRI scans are performed annually.
Medtronic’s new implants contain enhancements, a SureScan programming feature, and specialty leads designed to decrease or eliminate the potential hazards of an MRI scan.
“Delivering systems that are compatible with a full-body MRI scan means that spinal cord stimulation patients will not have to compromise when it comes to their healthcare, and they can feel secure knowing that MRI is a diagnostic option,” said Julie Foster, general manager and vice president, Pain Stimulation and Targeted Drug Delivery in the Neuromodulation business of Medtronic.
Neurostimulation devices treat certain diseases and pain by sending electrical pulses (and sometimes drugs) to a specific nerve. Most implanted neurostimulation devices and drug infusion systems are used to treat people with chronic pain, gastrointestinal disorders, spasticity, urologic conditions, and movement disorders.
Medtronic’s release of the new line of stimulators comes on the heels of its launch of a first of its kind global spinal cord stimulation study, called the PROMISE study, of patients with failed back surgery and low back pain. The study’s goal is to investigate the value of neurostimulation therapy in treating low back pain with accompanying leg pain.
MarketsandMarkets, a market research company in Dallas, reports that the global market for neuromodulation devices is poised to expand to $6.8 billion by 2017.