Spinal Cord Stimulator Gains FDA Approval for Full Body MRI Scan

Spinal Cord Stimulator Gains FDA Approval for Full Body MRI Scan

by Staff

One of the limitations of medical device implants are that they historically restricted patients from getting MRIs.  Device manufacturers have been working on new designs and materials to work around the challenge.

This week, St. Jude Medical announced in a press release that their Proclaim Elite Spinal Cord Stimulation (SCS) System has gained FDA approval for full-body MRI.  This means that people who use the system for pain control can undergo the MRI diagnostic scans

“This MRI Conditional labeling applies to both new patients and those already implanted with the upgradeable Proclaim Elite SCS System,” said Dr. Thomas L. Yearwood of Comprehensive Pain & Rehabilitation in Pascagoula, Mississippi. “I am very grateful that I can now safely expand access to the superior therapeutic outcomes offered by BurstDR stimulation to my patients who may need a full-body MRI in the future.”

St. Jude Medical’s BurstDR stimulation utilizes intermittent “burst” pulses designed to mimic the body’s natural nerve impulse patterns. BurstDR stimulation is a clinically proven to provide superior pain relief (as compared to tonic stimulation) by reducing physical pain and addressing their emotional response to pain as measured by visual analogue scale (VAS) scoring.

“The addition of full-body MR Conditional labeling for the Proclaim Elite SCS system will be another critical benefit for my patients and will help me ensure those who may one day need an MRI can benefit from St. Jude Medical’s innovations without fear of putting themselves and their implant at risk,” said Dr. Steven M. Falowski, chief of functional neurosurgery at St. Luke’s University Health Network in Bethlehem, Pennsylvania.

“Today, physicians treating patients with chronic pain need new therapy options that consistently put the patient first and ensure minimal disruption to their daily life,” said Allen W. Burton, M.D., medical director of neuromodulation and vice president of medical affairs at St. Jude Medical. “Historically, the need for future MRI scans could act as a barrier to patients who may benefit from SCS therapy. Our new labeling for the Proclaim Elite SCS system ensures that patients can receive BurstDR stimulation while having the peace of mind knowing their SCS system can be safely scanned with diagnostic imaging.”

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Authored by: Staff

There are 9 comments for this article
  1. Tim Mason at 4:36 am

    I thought about this article for awhile and thought I would comment again.
    One would assume that the MRI being done is not for a diagnostic issue that the SCS was implanted for!!
    One of the main contradictions for implantation is if the patient will need a total hip replacement at some time in the future.

  2. BDUBS at 11:54 am

    I’m just starting to learn about the SCS devices. There seems to be a lot
    of conflicting stories about complications and success rates. Clearly, the risk of complications is pretty high. However, It does appear that complication rates are coming down and a steady improvement in technology ( better lead placement, mri compatibility and smaller more powerful IPG units to name a few) is making the products much better. Much of the research seems dated and current patient experiences seem better. Is that what those of you who have done some research are finding. Best of luck to all! Thank you!!

  3. Maureen at 7:48 pm

    @Kristi M, thank you…I think that you may be absolutely right! I’ve had S/I joint injections in the past, they don’t help. The last time was about 4 yrs ago and the same doc couldn’t get into that space anymore…too much scar tissue from my surgeries.
    But, I know that there are S/I joint specialists out there…just not around me here in Fla.
    I’m also beginning to wonder if I have RSD (CRPS) in that area?? I have it in 2 other areas, left hip/thigh and right lower leg. I’m currently researching more about it.
    But again, trying to get a discussion rolling about it all with a doc is almost nil!
    I’m just very confused about it all these days.
    I ‘burn’ sooo bad at times in the L/S area, even with lying down and difficulty with sitting has been a major issues since my surgeries began, it has just worsened so much since about 2007. I had tons of pillows everywhere! 🙂

    @Tim, thank you also. Yup…the cascading effect is the haps with me! I have great foraminal narrowing, especially on the right lumbar right now with facet joint dysfunction. I’ve already had fusions at L3-4, 4-5.
    I have to mention…while I just love the things you post…
    I was recently reading an NPR post from last year where you mentioned the book written my Dr. David Kloth (and others). I just have to say this…
    I was a patient of his in CT…I was shocked to see that he wrote a book on pain management! My jaw actually dropped!
    He was a horrible horrible pain management doctor! I’ve met many others who also left his care. I will just leave it at that!

  4. Kristi M at 1:57 pm

    Maureen, Sounds like possible SI joint issues. I had the same problems as you described. i finally got injections into my SI joints and it helped immensely.

  5. Tim Mason at 8:21 am

    Maureen,
    Neurosurgeons and Pain Management do not see “eye to eye”. A neurologist will tell you if you keep getting surgery they will not be able to tell where your pain is coming from. I had an ALIF 360 2 years ago (single level) and the level above the fusion has an extruded disc. I have mild lumbar stenosis now and experience some of the symptoms you mention.
    I was actually able to get my surgeon and pain management doc to talk to each other and discuss my options. Their conclusion: No more surgery. An additional surgery to remove a disc above the fusion would cause my entire spine to begin collapsing (Its called the cascade effect). I said no to a SCS because I need another hip replacement. ( Patients possibly needing hip replacements are not a candidate for SCS- according to NIH.)
    Long story short- I moved from MSContin/Oxycodone to Fentanyl patches and oxycodone and I am so much better now.

  6. Gotnerve at 10:59 am

    Pls find a way to make DRG swim MRI compliant!!!

  7. Kim Applegate at 8:10 am

    Hopefully those of us who have SCS from other manufacturers ,that were implanted 2-3 yrs ago can benefit from this sometime in the future .

  8. Tim Mason at 7:00 am

    Looks like technology has improved for these devices. That’s good. Still the SCS should be the “method of last resort” for treatment.
    The patient should still be aware of the pitfalls that are in small print on the back of the CD or information packet that one receives to review prior to making an “informed consent”.
    Be informed, totally informed.
    A doctor wanting to reduce the amount of opioids or other medications from his or her practice in not a good reason to get one.
    If there is still “wiggle room” in your drug therapy-stay there for now.

  9. Maureen at 6:50 am

    Do any of you out there have this device yet? How is it doing for you?
    Coincidently, I just read up on this device last night. I saw my Pain Mgmt. Doctor on Friday for my monthly visit.
    I updated him on my recent CT Scan result and consult with a Neurosurgeon who has recommended yet another lumbar spine surgery (I’ve had four already)…
    this time it would be a facet joint fusion.
    For years, I’ve sworn off anymore surgeries. Meanwhile, due to previous fusions, my spine is collapsing causing new and different pain issues.
    I’ve already had one lumbar decompression surgery 3 yrs ago.
    My chief pain complaint is located in my low lumbar/sacral area… I can’t sit nor stand for long periods. I get such intense pressure in that area, as well as radiation into my legs, and MUST lie down, no matter where I am.
    Hence, why I mostly stay at home and isolate… I spend a lot of time lying down each day.
    And if I have to stand/sit too long…guaranteed I will suffer even more so later on and through the night. How that works is beyond me!
    I’ve yet to get to explain this to either my pain doc or Neurosurgeon. They just don’t let you talk!! It’s more or less ‘their way or the highway’!
    Anyway, I could go on and on about that issue but…
    back to Friday…my Pain doc was quick to recommend this St. Jude device when I mentioned that my pain levels are out of control these days and meds are barely cutting it anymore.
    I’ve already had the MedTronic Spinal Stimulator which failed for me 4 yrs ago.
    I’ve been in pain since 1990 and have been through it all….
    So, I am now up against another fusion?? OR, ignore that idea and try this newest stimulator and try getting off meds?! How did I get here again?!!
    It’s such a dilemma, with poor communication with those who want to cut into my body, AGAIN.
    I’m truly so tired of it all and find myself not being able to even digest/think about any of it. I just don’t know where to turn anymore…

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