Another FDA Approval For Spinal Cord Stimulation

Another FDA Approval For Spinal Cord Stimulation

IMG_6766Spinal Cord Stimulation has been around since 1989 as a treatment for chronic pain, and companies that make the devices are continuing to evolve their technologies, with what seems increasing speed.

The latest announcement comes from St. Jude Medical that the FDA has approved a system that is smaller than other devices and can be upgraded with new technology.

It’s called the Protégé MRI system, which the company claims will provide physicians with an option for therapy upgrades without the need for a future surgery.

Spinal Cord Stimulation is a standard treatment for patients with chronic pain who have not found pain relief from other treatments. While the treatment doesn’t work for everyone, most patients who qualify report up to a 70% reduction in overall pain.

It’s used to treat chronic pain of the trunk and limbs, often associated with back pain, failed back surgery syndrome, RSD and other neuropathic pain conditions. SCS systems have surgically implanted components and external components.

The three leading companies in SCS therapy are Boston Scientific, Medtronic and St. Jude. The treatment, which nearly a half million people have had, is also attracting new companies entering into the neuromodulation market, such as Nevro.

Regarding this week’s announcement, these comments from Robert Levy, M.D., Ph.D who is director of the Marcus Neuroscience Institute in Boca Raton, Florida were in the St. Jude press release.

“The Protégé MRI system provides physicians with a solution that offers the benefits of future therapy upgrades as they are approved without the need for a future surgery.”

“Going forward, patients implanted with a Protégé MRI system will not only have the ability to access future upgrades, but will also have the ability to undergo head and extremity MRI scans,” added St. Jude’s Eric Fain.

SCS, in simplest form, consists of a pulse generator with its remote controls, implanted stimulating electrodes and conducting wires connecting the electrodes to the generator.

What type of patients are the best candidates for SCS?

Appropriate patients for neurostimulation implants must meet the following criteria: the patient has a diagnosis amenable to this therapy, the patient has failed conservative therapy, significant psychological issues have been ruled out, and a trial has demonstrated pain relief. A trial period of stimulation over a period of 5–7 days should follow the psychiatric evaluation to demonstrate its effectiveness. This part of the protocol is important because of the cost of the equipment and the invasive nature of the procedure.

We are talking with two patients who are considering SCS therapy for their chronic pain. If they choose to go ahead, they will allow the National Pain Report to chronicle their journey.

If you’ve had SCS, let us know what your experience was like. We will share some of the comments with our audience in future stories.

Authored by: Ed Coghlan

There are 3 comments for this article
  1. Jamie Denny at 5:00 am

    i got mine December 2013 it worked just ok for the first couple months but then it developed a mind of it own. I really just want this thing taken out it does nothing since it broken for my pain!

  2. Julie at 1:50 pm

    I’ve had my SCS since May of 2013. It changed my life and made life worth living again. I can work and take care of my family again, where I was almost completely disabled before I got it due to failed fusion surgery. I highly recommend this unit to anyone who is a candidate. I urge them to at least give it a try. That was one thing I was so impressed with at the beginning, the fact that they let me try it out first. The second they turned the trial unit on, I had relief and I knew I wanted the permanent implant. I hobbled in that day, walking with a cane, and walked out straight as an arrow and without the limp that had become my normal walk.