“New” Recharge-Free Spinal Cord Stimulator for Chronic Pain Gets FDA Nod

“New” Recharge-Free Spinal Cord Stimulator for Chronic Pain Gets FDA Nod

A “new” recharge-free and upgradeable spinal cord stimulation (SCS) system for the treatment of chronic pain gained FDA approval this week.

The device, made by St. Jude Medical, is being billed as the “first and only” such system available to pain sufferers in the US.

With respect to “upgradeability”, the company stated, “The system’s upgradable platform allows patients to access future SCS technology upgrades, such as new stimulation waveforms and software updates, without surgical device replacement. Historically, most patients would need additional surgery to receive product upgrades as they are approved.”

The company’s statement did not clarify if this upgradeability was unique to the system, or if simply most patients historically attained new technology through re-implantation because recharge-free batteries used to require surgical replacement every few years when the battery died.

Regarding “recharge-free” benefits, the company stated, “The non-rechargeable system improves patient convenience by removing the burden of regularly recharging the SCS system.”

Interestingly, for decades the only type of SCS systems were recharge-free, and there were inherent problems with these systems, the main one being that the batteries would typically die within a few short years (sometimes less than 18 months) before needing surgical replacement.

In 2008, the first rechargeable spinal cord stimulation system was approved by the FDA and was considered a major breakthrough because the implanted batteries would last a decade or more than non-rechargeable ones. In addition, the amount of power available to deliver precise stimulation through rechargeable power was considered therapeutically beneficial.

That first rechargeable neuromodulation system was made by St. Jude competitor, Boston Scientific. Not long after, both St. Jude and Medtronic also developed rechargeable SCS systems, which set the technology tone for the last seven years.

So, why change back to the past?

According to the company’s press release, “the non-rechargeable system improves patient convenience by removing the burden of regularly recharging the SCS system.”

That inconvenience was more than a burden for a few patients, who in the early years of using rechargeable SCS systems were burned on the skin after recharging in a non-compliant way, such as falling asleep on top of the charging system. Those issues were later managed with safety controls.

“The approval of the Proclaim Elite recharge-free SCS system is a needed advancement for both patients and physicians who now have access to a low-maintenance chronic pain treatment that can reduce interference with daily activities,” said Timothy R Deer, M.D., president and chief executive officer of The Center for Pain Relief in Charleston, West Virginia.

While this “needed advancement” comes from the past, the real question is, will this recharge-free system last long enough before it needs to be surgically replaced when the battery dies to offset the inconvenience of charging up the battery?

The FDA approval also included conditional magnetic resonance (MR) labeling for the Proclaim Elite SCS system, which will allow patients to safely undergo head and extremity MRI scans.

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Authored by: Staff

There are 5 comments for this article
  1. Tim Mason at 12:11 am

    Christine,
    WebMD has a great deal of information on all aspects of the spinal stimulators. It is a good “one stop shop” for all the questions you have. Also, National Institute of Health http://www.nih.gov has numerous studies on brands, effectiveness, success rates plus many other statics.
    I did read that the spinal stimulators are installed by a pain management qualified or trained on implanting them. As for the hospital host the surgery, the pain management doctor is affiliated with one of the local hospitals in the area assuming you do not live in a rural area.
    I read that there is a trial period once you decide to go with one of the devices to see if it can help reduce your pain. I understood that everything is outside the body during the trial period except the wires that go into your spine or facet joints.
    The blog I read where people rated their effectiveness was varied. If helped some a lot and some it helped a little.
    This type of pain remedy is not for everyone. The “take home message” for me was that these stimulators require a great deal of patience to get used to. It can take up to six months for scar tissue to form around the nerve/electrode connection which is necessary for full effect.
    I am not a medical professional. I have had two lumbar surgeries and a hip replacement. I do need another hip and one of my shoulders has arthritis as well. I am planning on having an extruded L4,L5 disc surgically repaired this year.
    I just joined this blog last week and while mining it I came across your message.
    I wish you the best.

  2. Cdrocab at 3:02 pm

    My system is thru Boston Scientific and I just lost my tech consultant to a new one I have yet to meet. Charging visit no problem with my system and my control is fairly good but I do believe the L3 disc and R nerve root stenosis is still going to need to be surgically repaired. The quad muscle is getting weak and I’ve now got tingling in my toes. The main problem is that I want to go to the spinal doctor who did the stimulus placement even though the new pain management does them. As of yet I am not comfortable with this new govt controlled pain clinic but most of it is due to the antagonistic nurse techs who treat pain medication prescribees like criminals on parole. Eventually I will write a story on several of the terrifying episodes I have been through with these women who medical education wise are way below me and my Bachelor’s in Nursing. It’s a hard pill to swollow. Hardy Har Har.

  3. Cody arnold at 1:33 am

    Hey, Christina… my name is Cody Arnold, I live in Arizona and have been diagnosed with RSD, CRPS, and Perriferal neuropathy since 2009. Your comment caught my attention as it seems you are lost in this frustrating disease, I was very and still am somewhat lost but I do have a spinal cord stimulator so I a and I’ve been battling this disease with many doctors for quite some time. I believe I can answer most of your questions clearly and accurately to the best of my ability. Hopefully you will find this comment and can find a way to get a message back
    back. We need more people to SPEEK UP about these diseases and DEFEND these diseases. I’m tired of beeping labeled as an addict or a drug seeker because I’m in chronic excruciating pain but this pain is unlike any other and when trying to describe it to most doctors they instantaneously assume I’m searching for something…

  4. Diane Succio at 9:45 am

    I have had mine by Medtronic’s for a year and after 5 months another surgery to move my battery since it dislodged. Now it takes a total of 9 long hours done in 4 and 5 hour sitting. It does not work like the trail one did. So now I just have more scars for another useless surgery. My Dr now wants me to consider a pain pump and another surgery. I am quite frankly done with surgeries that do not work. Good luck with whom ever gets this.

  5. Christine at 6:19 pm

    I reside in New Jersey. What would be the outcome of this spinal cord stimulator? What hospital would perform this procedure? What type of Doctor would do this operation? Where does this operation happen? I have had Reflex Sympathetic Dystrophy since January 30, 2004. I am on permanent disability from The Society Security Administration. How much does this operation cost. It is quite obvious i have a lot of questions and I am hoping that I will NOT be ignored by anyone. I am requesting answers to all the above questions. Please, I am in need of a lot of help. I also do not want to be told that i am the wrong color, because that is just plain discrimination. I would appreciate for someone to get back to me who knows exactly how to answer all my questions that I have set forth this evening.
    Thank you for your anticipated cooperation regarding this very important matter.
    Sincerely yours,
    Christine A. Bopp