New Spinal Cord Stimulator Safe for MRI Scans

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.

97714_RestoreSensorMRI_Heroic_HRSpinal 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.

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4 Responses

  1. Messy Mark says:

    This is in response to Kay Redmon’s question & statement
    “After reading about this treatment, one would have to be very careful in weighing up the pro’s & cons before thinking about such a process.” For those of us that deal with debilitating pain day in and day out. We weigh the pro’s & con’s of such a procedure much more heavily than someone that does not have to deal with such pain. I can say honestly I have exhausted a lot of other options before considering this. I did therapy which = even more debilitating pain after each therapy session. Then pool therapy with the same outcome as the other.Then there was injections steroid,facet injections,nerve blocks which really had no effect on the pain. Then of course there is all the oral meds that by the time you are sitting at home on one of these oral regimens you sometimes look at all the meds and think hmmm I could almost open my own pharmacy. Then of course comes the family side of all the pain I happen to have a little girl who will soon be 7 years old and she is very active. Seeing I have had to deal with all this since she was about 3 I was confronted by her not to long ago with a question no father ever wants to hear . Dad how come you never lay down or sit down on the floor and play with me like my friends dad does ? So once the pain starts to interfere with your children and your home life almost anything that will relieve some of the pain may be considered. As to your question about an alternative to an mri for implant patients of scs devices or hardware . Most of the time it’s a cat scan or X ray some scs devices such as the Medtronics restore device. Here is a link to check it out if you would like http://goo.gl/ZUjT89 please take a look under the “Features Tab” it will explain about using an MRI with a Medtronics device. All in all my point to all of this is not to come of as being pompus at all. Just that pain can make your life a living hell and do some crazy stuff to try and get rid of it so for some people “Some things that sound to good to be true” Sometimes turns out to NOT be so bad for others because a little relief is better than no relief in the world of sever back and leg pain.

  2. Shelley Woelfel says:

    My neurostimulator installed in 2006 is a God send. I was bedridden for 8 months with terrible pain. It gave me my life back. My only problem, I also have MS, which meant they could no longer track my disease. What’s nice is this is also helping the pain from my MS, along with the herniated and bulging disc. I am getting ready to start a new MS treatment and just figured when my okd one died I could have mri taken before a new one is installed. This is great news that having a neurostimulator and mri’s are both possible. I hope its all for real and soon,

  3. Dale Robinson says:

    I have a cervical spinal cord stimulator since
    2003. If my doctor need any X-rays done . I
    either get a catscan done or X-ray.
    I got a spinal cord stimulator device card that
    Tell any metal detector agent to hand pat me
    down .
    I still have my same battery , I do not turn the unit
    On pass three or four. I turn the turn on three times
    a week because I now suffer from
    occipital neuralgia migraine .

  4. Kay Redmon says:

    After reading about this treatment, one would have to be very careful in weighing up the pro’s & cons before thinking about such a process. What alternatives are offered to those who cannot have MRI’s because they have metal implants ???
    Some things that sound to good to be true, often turn out to be just that…

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