First Neurostimulation Technology for Chronic Pain Designed for Full-Body MRI Safety

The first implantable neurostimulation, also known as a spinal cord stimulation (SCS) system, designed for use in the treatment of chronic, intractable back, and/or limb pain, has been approved by the US Food and Drug Administration (FDA) for conditionally safe, full-body magnetic resonance imaging (MRI) under specific conditions.

Until now, SCS patients referred for a body MRI were denied a scan because to worries about the system being affected by the large magnetic fields and radiofrequency (RF) energy involved in MRI. Medtronic’s (Minneapolis, MN, USA) RestoreSensor neurostimulation system with SureScan MRI technology and Vectris SureScan MRI percutaneous leads are specifically designed with enhancements to reduce or eliminate the dangers generated by the MRI environment. The systems also include a proprietary SureScan feature, which sets the neurostimulator into a suitable mode for the MRI setting, enabling the radiology departments to easily and effectively validate a patient’s implantable system is safe for MRI scanning.

Among the first physicians to implant these new systems are neurosurgeon Ali Rezai, MD, professor and director of the Center for Neuromodulation and Functional Neurosurgery at The Ohio State University Wexner Medical Center (Columbus, USA), and president of both the North American Neuromodulation Society and Congress of Neurological Surgeons; David L. Caraway, MD, PhD, medical director for St. Mary’s Pain Relief Center (Huntington, WV, USA), and a member of the board of directors for the North American Neuromodulation Society and executive vice president, American Society of Interventional Pain Physicians; and Mehul J. Desai, MD, MPH, director, spine, pain medicine and research at Metro Orthopedics and Sports Therapy (MOST; Silver Spring, MD, USA).

“The ability to safely perform MRI scans after a spinal cord stimulator implant is an important advance and a major benefit for our patients,” said Dr. Rezai. “In today’s medical practice, MRI examinations are necessary and routinely performed for diagnosis and clinical care. It is very likely that a patient with chronic pain, spinal disease, neurological and orthopedic disorders will require an MRI scan. However, until now, this was not feasible with SCS implants. I am happy that we will now be able to offer MRI scans for our patients.”

The systems received FDA approval in March 2013 and CE marking in January 2013. “The approval of Medtronic’s SureScan neurostimulation systems means patients finding relief from their chronic pain with neurostimulation therapy can feel confident knowing they have access to an important diagnostic tool without compromising their healthcare,” said Julie Foster, general manager and vice president, pain stimulation and targeted drug delivery in the neuromodulation business of Medtronic, Inc. “This latest innovation is yet another example of our ongoing commitment to provide clinicians with safe, effective solutions to meet the needs of their patients.”

Medtronic SureScan neurostimulation systems with Vectris SureScan percutaneous MRI leads for chronic pain are the latest additions to a growing number of existing Medtronic devices that are designed for MRI access. These include the Medtronic SynchroMed II programmable drug infusion system and Medtronic SureScan pacing systems, which are available worldwide.

Medtronic neurostimulation therapy for chronic pain uses a medical device placed under a patient’s skin to deliver mild electrical impulses to the spinal cord, which act to block pain signals from going to the brain. In 2011, the FDA approved Medtronic’s AdaptiveStim with RestoreSensor, the first neurostimulator to incorporate motion sensor technology to help treat chronic pain. The innovative system uses a proprietary sensor and algorithm to automatically detect and respond to changes in the patient’s body position, resulting in effective pain relief and convenience.

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