A new type of spinal cord stimulator that is compatible with magnetic resonance imaging (MRI) is now being used in the U.S. to treat chronic back and leg pain. The Food and Drug Administration gave Medtronic (NYSE: MDT) approval to use the “SureScan” device in March and it was recently implanted in the first patients around the country.
“It’s the first real pain relief I’ve felt in a long, long time,” said Deborah Stephens of Merriam, Kansas, who suffered from chronic pain in her right leg caused by degenerative disc disease.
Spinal cord stimulators (SCS) implanted in the spine as part of neurostimulation therapy give relief to pain patients by sending electrical pulses to a specific nerve, turning pain signals to the brain into a tingling sensation. But they also made full-body MRI scans unsafe, because the stimulators could be damaged by the magnets used in an MRI.
MRI scans are an important diagnostic tool for physicians to view detailed images of joints, muscles, blood vessels, tumors and internal organs.
Medtronic’s new implants, which have been available in Europe for several months, have specialty leads designed to decrease or eliminate the potential hazards of an MRI scan.
“MRI is the standard of care in diagnosis and treatment of major health conditions including cancer, stroke and neurological problems,” said Talal Khan, MD, director of pain management at the Marc A. Asher Comprehensive Spine Center at the University of Kansas Hospital.
“This technology opens wide the door for us to help many more patients in pain without the side effects often associated with narcotics or the risks of multiple surgeries to remove SCS before an MRI.”
This video report shows how Khan implanted the SureScan device into Deborah Stephens during an outpatient procedure at the University of Kansas Hospital:
Another patient, 78-year old John Garvin of Worthington, Ohio, had the SureScan stimulator implanted at Ohio State’s Wexner Medical Center to help relieve intense foot pain caused by peripheral neuropathy.
He’s now looking forward to spending pain-free time playing with his grandchildren, walking his dog and attending Ohio State football games.
“This is a no brainer. I wouldn’t continue on with this pain for 10 minutes longer than I’d have to,” said Garvin, who was worried about getting other stimulators because he’s needed MRIs in the past.
Ohio State neurologist Dr. John Kissel, who treated Garvin for almost two decades, said he suggested Garvin for the surgery because multiple medications were no longer helping to relieve his pain.
“The stimulator will improve his life by reducing his pain, increasing his ability to do routine activities, and hopefully lowering his need for medications,” Kissel said.
It’s estimated that 60 million MRI procedures are performed worldwide each year, including an estimated 32 million in the United States.
“MRI examinations are necessary and routinely performed for diagnosis and clinical care. It’s very likely that a patient with chronic pain, spinal disease, neurological and orthopedic disorders will require an MRI scan,” said Ali Rezai, MD, who is president of both the North American Neuromodulation Society and the Congress of Neurological Surgeons.
“These spinal cord stimulators can help patients who suffer from extreme back, leg and extremity pain, especially those patients who have failed all previous medications and other approaches to get improvements in their pain and quality of life and functioning.”
MarketsandMarkets, a market research company in Dallas, reports that the global market for spinal cord stimulators and other neuromodulation devices is poised to expand to $6.8 billion by 2017.
But the stimulators and other implants also come with risks. National Pain Report columnist Mark Maginn recently wrote about his own experience with a Medtronic spinal cord stimulator.
Maginn said it gave him “minimal relief” and over the years he found himself using it less and less. The device was damaged when Mark slipped on ice and fell on his back, leaving him in intense pain. He now wants the stimulator removed.
Medtronic recently said that 14 patients died from complications caused by defects in an implantable pain pump. The pump is used to deliver analgesic drugs directly to the spinal fluid in patients with intractable pain or severe spasticity.
Device maker Boston Scientific (NYSE:BSX) is currently being sued in federal court by two former employees in a whistleblower lawsuit claiming the company committed illegal acts in relation to its Precision Plus spinal cord stimulator. The lawsuit alleges the company submitted fraudulent Medicare and Medicaid billing claims, concealed defects in the stimulator, denied replacement devices, engaged in a kickback scheme, and retaliated against employees who complained about such practices.
Boston Scientific has asked the court to dismiss the lawsuit and to award the company legal fees and monetary damages.