New ANS spinal cord stimulation lead for patients with low back pain

St. Jude Medical, Inc. has announced U.S. Food and Drug Administration (FDA) clearance of two spinal cord stimulation tripolar paddle leads for use with the Renew Neurostimulation System.

With three columns of electrodes, these leads allow physicians more programming options to address complex pain patterns.

The leads were developed by St. Jude Medical’s neuromodulation division, Advanced Neuromodulation Systems (ANS).

The Lamitrode Tripole 16C and the Lamitrode Tripole 8C are designed to help patients suffering from one of the most common and difficult-to-treat patient indications, neuropathic low back pain. Often described as an intense burning or stabbing pain, neuropathic pain can be caused by an injury to nerves or by an underlying disease or dysfunction.

The Tripole 16C is the first three-column paddle lead with 16 independently activated electrodes, which can be programmed to send mild electrical pulses to low back nerve fibers while minimizing unwanted stimulation. These independent electrodes can also be programmed to provide stimulation to multiple areas for those patients who have pain in more than one area of the body.

“Low back pain is one of the most difficult pain patterns to treat,” said Gerald Hale, D.O., of Tulsa Integrated Pain Services in Tulsa, Okla. “The development of these new paddle leads improves our ability to treat this area through targeted, sustainable stimulation therapy.” Dr. Hale was one of the first to evaluate the design of these leads.

In 2004, ANS was the first to introduce a tripolar paddle lead. The Tripole 16C and Tripole 8C are the first tripolar leads with a curved surface to conform to the cylindrical shape of a patient’s spine, which is designed to make them more stable and less prone to migration.

“We are committed to developing new lead technology that provides physicians with the widest array of lead options, so they can choose the best lead to address each patient’s need,” said Chris Chavez, president of ANS.

Pain is a serious and costly public health issue, and it remains largely under-treated and misunderstood. According to the National Institutes of Health, 90 million people in the U.S. suffer from chronic pain. The American Pain Foundation estimates that chronic pain costs approximately $100 billion a year in lost work time and health care. More than 30,000 patients in 25 countries have been implanted with ANS spinal cord stimulation systems to treat chronic pain of the trunk and limbs.


  1. Jack Harrison Jack Harrison United States says:

    I am scheduled for an ANS spinal implant in a few weeks. However, I have concerns for mechanical failures and surgical complications. I have not been able to find very many positive comments regarding the success of this form of pain management. Some patients have experienced more pain and suffering with the ANS SCS. Has anyone had good experience with theirs?



    • Kathy Kathy United States says:

      i had a low back injury has several major surgeries all that it left me with was constant burning in my hip and my legs were on fire 24/7...i went in and had the trial scs implanted and while i was on the table my leg pain went away immediately...i suffered with pain, tingling.numbness in my legs for 8 years..i never heard of SCS.till a family member out of state in the medical field said why dont you get a SCS..we had no idea what that was. so we researched it and 3 months later found a doctor that did these and since the day they put it in my back i have no pain in hip of burning down my legs...any one out there that has had nerve pain burning there hips and fire in there legs no that it will make you crazy from the pill helps the matter how strong the narcotic...But the SCS is a life changing surgery for me i would do it not have leg and hip pain is like winning the lottery....

    • Kathleen Sullivan Kathleen Sullivan United States says:

      i have had the low back stimulator since 2006. I had constant
      Burning/stabbing unbearable pain in my legs, hips, butt, and back. I had been dealing with this pain since 1999.  Then in 2006 I had the "test trial" Stimulator implanted in low back. I could not believe this was working. I had been on every narcotic out there on ridiculous doses and yet I still Had burning/stabbing.

      I cannon say enough good things about my stimulator. I would not no what  to do without it. If you have had leg pain you no how all consuming it can be. To have a surgery that stops the burning and you are in control of how high or low you can have your stimulator is incredible..if you are suffering you don't have to this works. I don't get paid by anyone to say these things, I'm a regular person who suffered for years and years with this debilitating pain, you don't have to suffer anymore.

    • Randy Rice Randy Rice United States says:

      Jack I've got the trial ANS and it works okay sometimes but it cuts off and on and drives me crazy but I will try the permanent one soon it does seem to help

  2. Dianna Lazan Dianna Lazan United States says:

    This technology is a lifesaver. With all procedures, you can encounter problems, but neurostimulation WORKS!! After my leads migrated, I had to have a revision and have had postop infections, but it was worth the pain relief. I am waiting for new leads. If your pain is disabling, as mine is, it is worth it, even shaving my long hair off for 2 years.

    If you do get an infection, go to Infectious Disease immediately. I have a compromised immune system, but most patients are fine.

  3. Michael Michael United States says:

    A friend recently told me he had heard something about spinal implants causing cancer...would the ANS implant be involved with this or any other medical malady from implantation??

  4. Dennis Dennis United States says:

    I just had an ANS SCS implanted and even though I'm still sore from the operation, It has deinatley reduced my pain levels to the point that when the implant sights heal completly I might be able to walk away from the pain meds. And after taking things like oxicotin, morphin, percocet, vicoden, soma, and many more to get my pain under control. To me this SCS is a blessing.

  5. gary greenfield gary greenfield United States says:

    Why does the ANS proceedure require the "TEST Stimulator" to be replaced with a "permanent stimulator" after three days of positive results.

    Why, then ; does the "permanent stimulator not deliver the FANTASTIC RESULTS , which the TEST stimulator delivered?


    Why have we only learned of one wire from the 1st "DOC", two wires from the 2nd , and 3 wires in this E mail ????

    Now that we as a couple have lost 10 years of our lives, does anyone care to help ?

  6. Jama Graham Jama Graham United States says:

    In 2004 I endured a botched attempt to implant of another brand of pain stimulator.  I had a most successful trial and was anxious for pain free days.  The surgeon botched that procedure.  Long recovery.  Then another Dr., another city, more shots, treatments, and finally another trial was scheduled.  This Dr. Said the ANS would be best for me.  During her attempt to place the leads, I felt everything she was doing.  The next day, the lead simply pulled out.  Dr decided to go proceed w/o a trial.  The reps were unable to program the device to do what I was told it would and could do.  Many, many times, reps from St Jude traveled to my town, meeting me at my  local Dr's office where we would attempt to program the device.  Never could.  Kept the device charged, kept trying, for more than four years.  The stimulator was removed Sept. 2012.  I requested that It be given to me.  I believe it was defective, and/or the leads were not placed correctly.   State regs. Would not allow.  After the removal, I began to have trouble walking. On Dec. 24, 2012, lost the use of my legs totally.  Jan. 8, 2013, another spinal cord surgery.  While I amazed the Dr's I survived that surgery, they were more surprised that I can walk.  Still wobble , but ever so thankful that I can walk.  I take no narcotics for pain and have not since a week after the Jan 8 surgery.

  7. Clint Largent Clint Largent United States says:

    I just had my ANS stimulator removed because it didn't do what the trial version did. Now after having it taken out my pain level for my blown out back is also less-I was in too much of a hurry to have it implanted because when you are in pain you will jump through hoops you never thought you would jump through. I finally have a life again and I think if I had held off from having it implanted the natural healing would have occurred sooner. It was in my body for 4 years and when i was using it I had to turn it up so high that it made my feet numb. Bad experience -please think twice before having it done.

    • Traci Manuel-Thomas Traci Manuel-Thomas United States says:

      I have 3581 and and is have shocking in my spine and burning and shocking under the battery with over heating and my I still can feel the pain in my right hip. I want it out!

  8. James Haman James Haman United States says:

    I have a ANS stimulater  and I am not happy with it. That thing has  change my body function.. I have to
    get this thing out of me.I am ,having all kinds of personal problems ..going to the bath room all the time..falls because right leg just gives away  at
    times .when trying to use  it. PMA has taken my meds away and I am trying to deal with this old ANS stimulate.. For two weeks no meds for my back.. Was this old ANS  simulated approve  FDA back in the day. Its junk .
    Hope you have better luck then me. No one better not ask me to putting ANS  stimulater in my back.

The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News Medical.
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