Medtronic has announced that it is introducing the first and only implantable system for use in the treatment of chronic, intractable back and/or limb pain that is approved by the US Food and Drug Administration (FDA) for conditionally safe, full-body magnetic resonance imaging (MRI) under specific conditions.
As advancements in technology have increased accuracy, effectiveness and patient comfort, MRI use has grown dramatically in recent years. Worldwide, it is estimated that 60 million MRI procedures are performed each year. In the USA, the number of scans has nearly doubled in the past decade, with 32 million scans—more than one MRI per second—performed in 2011, according to a press release.
Until now, spinal cord stimulation patients referred for a body MRI were denied a scan due to concerns about the system being affected by the large magnetic fields and radiofrequency energy involved in MRI. Medtronic’s neurostimulation systems with SureScan MRI technology and Vectris SureScan MRI percutaneous leads are specially designed, according to the company, with enhancements to reduce or eliminate the hazards produced by the MRI environment. The systems also include a proprietary SureScan feature, which sets the neurostimulator into an appropriate mode for the MRI environment, enabling the radiology departments to easily and conveniently confirm a patient’s implantable system is safe for MRI scanning.
Among the first physicians to implant these new systems are neurosurgeon Ali Rezai, professor and director of the Center for Neuromodulation and Functional Neurosurgery, 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, medical director for St. Mary’s Pain Relief Center in Huntington, 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, director, Spine, Pain Medicine and Research at Metro Orthopedics and Sports Therapy (MOST) in Silver Spring, 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 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 orthopaedic disorders will require an MRI scan. However, until now, this was not feasible with spinal cord stimulation implants. I am happy that we will now be able to offer MRI scans for our patients.”
The RestoreSensor SureScan MRI neurostimulation system is one of a portfolio of new Medtronic neurostimulation systems. The systems received FDA approval in March 2013 and CE mark approval in January 2013.