FDA Approves St. Jude’s BurstDR SCS Therapy for Chronic Pain

FDA Approves St. Jude’s BurstDR SCS Therapy for Chronic Pain

A new form of spinal cord stimulation (SCS) therapy called BurstDR gained FDA approval today, adding to the growing number of options in the field of neuromodulation.

Its manufacturer, St. Jude Medical, said the new technology provides superior outcomes over traditional SCS therapy.

Last week, National Pain Report wrote about another type of spinal cord stimulation therapy called the Senza HF10, which, too, was shown to provide better outcomes than traditional SCS therapy.

“As a physician, reducing the physical sensation of pain experienced by my patients is only part of my job; my ultimate goal is to help patients overcome both the physical pain and the suffering associated with their pain,” said Dr. Timothy R. Deer, president and chief executive officer of The Center for Pain Relief in Charleston, West Virginia.

“Now, with BurstDR stimulation, St. Jude Medical has armed physicians with a new therapy option that can reduce patients’ pain and suffering, reduce paresthesia and help us offer our patients a more complete pain management option,” Dr. Deer added.

BurstDR stimulation utilizes intermittent “burst” pulses of electrical current designed to mimic the body’s natural nerve impulse patterns.  The technology was evaluated within the SUNBURST study, a prospective, randomized multicenter study which concluded it offered superior pain relief over traditional SCS and that the therapy was preferred by most patients over traditional SCS therapy.

“I am very excited that patients across the United States will now have access to BurstDR stimulation, which has enjoyed strong success across other global markets,” said Prof. De Ridder, from the University of Otago in Dunedin, New Zealand. “When I developed BurstDR stimulation my goal was to introduce an entirely new therapy option, and one that was rooted in the natural way in which the human body responds to and combats the sensation of pain.”

“Chronic pain is one of the most costly epidemic diseases facing health care systems worldwide, and one of the most challenging for physicians to manage due to the complexity of the condition and the differences in each patient’s clinical case,” said Allen W. Burton, M.D., medical director of neuromodulation and vice president of medical affairs at St. Jude Medical. “With FDA approval of BurstDR stimulation, we are empowering physicians with a new therapy option in their fight against widespread chronic pain, and our goal is to continue to improve patient outcomes and get more patients the pain relief they deserve.”

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Authored by: Staff

There are 8 comments for this article
  1. Nashur Whattodo at 4:40 pm

    All I have to say about the “stimulator” is, my Father took his own life while using a stimulator. It did not work, for him. WHY can the CDC not accept that some of us have already been exposed to ALL the alternative options to ease pain. I have been told by my orthopaedic doctor, my general M.D. and by my chronic pain management specialist that I have no…..further….options. I really don’t like being forced to adhere to so many regulations set forth by all my physicians but, I realize that hey are conforming to the laws set forth by the regulating agencies to prescribe me opioids in the treatment of my non cancer chronic pain. If I had an option that worked and would ease pain sufficiently so that I may take care of myself and the loved ones that I am responsible for, I would take the option. Mary and Jay don’t know what to do either. It seems the last option some of us have is being removed by the governing authoritie, the CDC.

  2. Chuck at 6:46 pm

    If a sufferer has been Conservative, cooperative and compliant and has gotten years of relief from opioids with no serious side effects, rapid tolerance or “new pain pathways” and they tell the provider for example, ..” I would get significant improvement in function and reduction in pain if you would prescribe me X” .. then why are they not trusted and why not give it a try for a month or two. Do these “care” providers have a clue how much needless suffering they are imposing on us? I still get Rx for “breakthrough pain” after 14 years where the pain is never NOT breaking through. It is crazy making to the extreme and we are tortured needlessly. Why not get some chronic pain veterans on these committees and boards and panels. We will cut through the cr*p and make a big difference in a big hurry.

  3. Chris at 10:06 am

    Angelica — I take offense with someone who minimizes and dismisses my experiences. I find it funny that you state that one should do their own research and decide what’s best for them. That includes the negative outcomes and experiences of others. To only research the positive outcomes is not in anyone’s best interest. The reality is that these devices have been around for years and the “new and improved” is exaggerated. The fact that the article states that this technology offered “superior relief” over traditional scs is suspect. Everyone should do their due diligence and decide for themselves what interventions they want to attempt. I am glad that some have had positive outcomes from these devices. I have learned, with time and experience, to question claims that seem “too good to be true”.

  4. Angelica Heavner at 6:53 am

    The one thing I seem to see constantly is the bad responses. Remember not everyone is the same and no one treatment option works for everyone. Every time they come up with something new or improved all I see are the negative comments. That needs to stop as there are people getting diagnosed every day that are looking for options and all the negatives isn’t fair to them. Remember it might work for them even though it didn’t for you.
    I had my neurstimulator put in in 2012 a yr after diagnosis. I had already lost complete use of my right hand and wrist due to RSD/CRPS and doctors that didn’t want to treat correctly early on. After allergic reactions to a ton of medications and failed blocks I was ready to amputee my hand and wrist to stop the pain. The stimulator helped reduce my pain to tolerable levels so I could function. Does it remove all pain?, no, and anyone that tells you it does is lying. Yes there are risks but you need to do your own research and make your own choice on whether its a chance you are willing to take. Dont listen to all the negative because everyone likes to complain when things don’t go the way they want. There are postives and people these help.

  5. Judy Jaeger at 1:24 pm

    No way I’d ever consider spinal cord stimulation, I’ve heard too many horror stories.
    Been living with chronic pain for 24+ years……I’ll be living with chronic pain until I die.
    FDA approved means nothing to me anymore….too many of the medications I’ve been prescribed over the years have only contributed to my many health issues.

  6. David at 7:59 am

    New and improved goods and services piled on new and improved goods and services are all too little to make pain care much better or different then it is. But, of course the medical profession doesn’t have a moonshot for people in pain-what they have is more moonshine for people in pain- in the form of treatments that fall far short of what is needed to improve the lives of people in pain.
    I understand Dr. Deere believes that market fundamentalism is the answer to all issues in pain care. And yeah Ive read his large books on pain care and don’t see evidence of independent, critical or diverse though in them. And so Dr Deere wants a dated and ineffective paradigm to continue indefinitely regardless of its inadequacies for people in pain. There’s no evidence of reflective practice in his market fundamentalism. He wishes us to buy into a failed approach to pain that is profitable to pain specialists but .So the approach of Deere at al is a very truncated approach- and an approach that has failed to lower the costs or prevalence of pain care or significantly reduce symptom, adjustment or treatment burden for people in pain.
    Once again pain “experts” cant get pain care right. Its right for them as it is profitable and doesn’t demand they make substantive improvements to their practices beliefs, values or morals.

  7. Chris at 12:49 pm

    How about we invest in studying new technology and not just repackaging the same old devices that have rendered less than impressive results for the majority patients. I’ve had a spinal stimulator and neurostimulator implant and neither provided any long-term relief for my pain and left me with additional pain that has never subsided. Mine were both through St. Jude Medical and, when I encountered issues with the devices, I had to fight to receive support from both the doctor who implanted the devices and the company’s representatives. I was told on more than one occasion that they do not compile long-term data on the performance of these devices. Till this present day, I still receive calls from this company because they have no record that my devices were removed! I’ve provided this information (along with the dates each was removed) each and every time I’ve received a call. I was originally told they would check out my device after its removal to ensure it had not malfunctioned — clearly this never happened. Because of my experiences, I will never allow another device to be implanted in my body. Trust me, when things go wrong, you’re on you’re own!

  8. John S at 10:56 am

    “BurstDR stimulation utilizes intermittent “burst” pulses of electrical current designed to mimic the body’s natural nerve impulse patterns. ”

    Having severe spinal nerve damage I can say that there is nothing normal about how the damaged nerves in my back and legs work – normal isn’t how I would describe the sensation.

    Years ago after I noticed Twitching in my left calf muscle I attributed it to a spasm. My neurologist told me it’s caused by the nerves being damaged and the muscle atrophy setting in.

    I had a SCS implanted back in 2007 then 3 more operations to reattach the lead wire after it moved just 1 cm. Doctors were unable to reproduce the former positioning and were forced to remove the device. The end result was more scar tissue, more arthritis and more instability in my back and now bone spurs.

    My point is – these things are a crapshoot and quite often can cause more harm than pain relief. For me the process didn’t work but might work for others that don’t have the damage I have.

    If this new stimulator mimics the normal nerve impulses how can it help the patient with abnormal nerve firings or none at all ?

    After the SCS was removed my doctors told me the only other option left ( that I had not tried ) was a Pump that would deliver medication to the area causing the most pain. I saw how it worked and the long list of possible complications like infection ( most common ) and others.

    I was asked if the oral medication I was taking was doing the job for me and I said YES. The opiate medication I had been on was delivering enough pain relief to keep me working full time and allowed me to live a fairly good life. That being the case I was no longer considered a candidate for the pump.

    The anti opiate campaign has produced hundreds of new products all in the name of – opiate free pain relief. I hope soon a better drug or devise is developed for my condition.

    For now opiates have worked for me and it’s going on 15 years of using them along with other modalities that help.

    Thank you,

    John S