Medtronic Gets FDA Nod for MRI Compatible Neuromodulation System for Chronic Pain

Medtronic Gets FDA Nod for MRI Compatible Neuromodulation System for Chronic Pain

Medtronic’s new Specify SureScan surgical lead gained FDA approval, making its spinal cord stimulation system compatible with a full-body MRI scan, the company stated in a press release.

This allows people with intractable back or limb pain who will be implanted with the new lead to undergo full-body MRI.  The company cited a study that shows 82% of patients implanted with a spinal cord stimulator are expected to need an MRI within five years of receiving their implant.

MRI scans are a diagnostic standard that allows physicians to detect and diagnose a wide range of conditions by viewing highly detailed images of internal organs, muscles, joints, and other systems in the body.  MRI uses powerful magnetic fields and radio frequency pulses that create detailed images of systems and structures inside the body.

“All patients with a spinal cord stimulation system should have the ability to be offered the same imaging options as those without one,” said Steven Falowski, M.D., neurosurgeon at St. Luke’s University Health Network in the press release.

“Now more than ever, patients and other health care providers are concerned about access to MRI when considering an implantable device.   This approval means I can offer a neurostimulation system that helps manage my patients’ pain and gives them access to the diagnostic benefits of MRI,” Dr. Falowski added.

Medtronic (NYSE: MDT) cited statistics showing that back pain affects 8 out of 10 people at some point during their lives, and went on to say, “for some people, noninvasive options, such as medication and physical therapy, provide adequate relief; others may require surgery, nerve blocks, or medical devices, such as spinal cord stimulators or drug pumps. Spinal cord stimulators are medical devices implanted under the skin that send mild electrical pulses to an area near the spine. These pulses disrupt the pain signals traveling between the spinal cord and the brain, offering patients effective pain relief and improved function.”

National Pain Report has covered many advances in the field of neuromodulation, including new companies entering the market and new methods of delivering pain-relieving stimulation to the spinal cord.  You can read more here.

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Authored by: Staff

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Linda Yoak

I have 2 Medtronic Spinal Cord Stimulators I like the rechargeable one better the battery in the non rechargeable ones have not lasted me 2 years I am on number 5 & 6 now I drive a car I use a microwave and my cell phone I also take time released morphine and another fast acting morphine for breakthru or sudden uncontrollable pain in the whole left side of my body I am allergic to almost every know pain medication and have had several back and neck surgeries the last one was back surgery with rods,cages and screws my low back was so bad I used a wheelchair so I am very happy to use my Stimulators and am waiting to get the new rechargeable ones that are MRI safe I was a nurse practitioner that was injured on the job in 1988 after way to many spine injections that rarely worked and caused weight gain and lots of other medical problems including high blood pressure and diabetes from intense pain I have used meditation and now with my Stimulators my sugar is under control without medicine and so is my blood pressure with 2 different low dose medicines that I take at night that also help with sleep my amount of medication is lower than ever I also use supplements like black seed ,coconut oil capsules B12, and raspberry ketone the cold weather here is impossible to tolerate in winter so before I lost my husband in a work related accident we had been spending out winters out west in Arizona and Texas and California as he did asphalt and was off in the winter I plan on moving to Texas or California and only living here in the summers and returning home for the holidays with my kids and grandkids I know most people cannot do this but I am lucky to have a twin sister that has a home with lots of extra room for me in the winter as all our kids are grown with their own homes so when it’s to hot in Texas her and her husband come here and I go there when it’s to cold here I know that there will always be pain and suffering for all chronic pain suffers it took over 18 years to get to where I am I only pray it does not take so long for others next step is a pain pump that uses a long acting numbing drug like my lidocaine patches and not have to use morphine except for the really bad pain occasionally that is what I am aiming for I was against a morphine pump but with new pumps and meds that are not morphine this can make it easier to enjoy my grandkids and make crafts,sew,and bake without waiting for warm weather and a good day I think Medtronic Stimulators are the best thing to have made me be better or as my family says it’s so good to have… Read more »

Carly C

I also thought that the article would have done well to explicitly state, for the uninformed reader, exactly why MRI is currently contraindicated for most SCS-implanted patients. As I understand it, the equipment heats up internally, causing potential discomfort or damage, and the MRI’s magnetic field damages the function of the SCS, rendering it unusable - therefore ruling out MRI in all scenarios except for grave medical emergencies. Is someone at the National Pain Report able to comment on this?

Carly C

In response to Tim’s comment, I am able to use my SCS whilst driving, in proximity to microwaves, mobile phones, and in all areas of a hospital, say, where mobile phone use is not permitted - the MRI suite, of course, being the exception. My stimulator charges within 30 min every few weeks, and the charger can clip onto a belt (I have my IPG implanted in my abdomen for this precise reason) and doesn’t require that I sit stock still.

The sensation is indeed unusual, and, at the higher levels of stimulation, not entirely comfortable. It is, however, something one can get used to (particularly if the coverage, the area in which stimulation is perceptible) maps the pain area well. I certainly prefer the sensation of the stimulator to the untempered pain sensation.

All of this is not to say that an SCS is a panacea. I have personally experienced frustration & problems with my SCS, and whilst it sometimes dials the pain down, it doesn’t mitigate it completely (or anywhere near completely!) It is an imperfect solution to a complex problem. I think that many pain patients, by the time they reach the stage of needing an SCS, are realistic about the fact that there is sadly no silver bullet for this condition. As such I think it is important to recognize that there are risks and benefits to every potential treatment, and there is great value in understanding your options, and researching verified, good information. There are a lot of misconceptions out there, and it doesn’t help to promulgate false information or scare-monger. There is certainly a long way to go in terms of developing the best possible solution to intractable chronic pain.

Tim Mason

There are many drawbacks to the “spinal stimulator” that are in very fine print. They can and do overstimulate when passing thru an antitheft device at a store. You can not wear it while driving. Being near a microwave is a big no-no. If could even be that you cannot even use it anywhere cell phones are not allowed.
People complain of overstimulation, non-stimulation, the sense of something foreign in your body and having to remain still for four hours while the recharging is done.
It also seems to me that spinal stimulators should have come first and then a pain medication that works.

J Rae

Dave, I agree 100%. Many physicians are afraid to prescribe opioid pain meds because of the CDC trying to establish guidelines on opioid protocols, and the DEA targeting pain doctors that prescribe reasonable amounts of opioid pain meds to legitimate pain patients. Many pain patients can’t tolerate NSAIDs or opiates, or they don’t work. Physical therapy, TENS units and weight loss doesn’t work for many of us, either. We need more options.

Jean Price

Well, I suppose this could be important. Most implanted hardware causes artifacts, so the value of MRIs is always iffy on the affected area when patients have implants of any size. I guess it would be a good thing for those needing a diagnostic procedure on another area though. Wonder what the difference in cost is??


Its unfortunate companies cant develop much different and better pain treatments. We have a lot of tweaking in device manufacturers and drug manufacturers. But bold new methods are needed to move pain care forward. And it is clear industry is not up to the challenge. Whether it is because they don’t need to for economic reasons or because they don’t know how- it is clear they have failed the American public when it comes to innovations that make enough of a difference to the lives of people in pain.