What to Know About a Spinal Cord Stimulator Replacement

hey guys I’m DR paul lynch I’m an anesthesiologist and pain management
doctor from Scottsdale Arizona today I’m coming to you to talk about HFX
welcome to our on-demand webinar a next-generation approach to the spinal cord stimulation
this webinar is for people who have tried a traditional spinal cord
stimulator and didn’t experience relief or are up for a battery change and would
like to re-evaluate your treatment options or would just like to learn the
difference between traditional spinal cord stimulation and HFX
what are we going to talk about today well I’m going to talk to you about when
to consider upgrading your device I’m also going to talk to you about some of
the limitations of traditional spinal cord stimulation versus HFX I’m going to
talk a little bit about the clinical evidence demonstrating long-term relief
with HFX and then I’m going to get into what to expect during the replacement
procedure I’m going to finish off with some insurance coverage issues because
we know we can’t get any of this done without the insurance being behind it
so let’s jump right into when should you consider upgrading your spinal cord
stimulator well first of all if your current traditional stimulator doesn’t
provide you enough relief for your painful areas you should talk to your
doctor about upgrading if you tried a traditional spinal cord stimulator
before and you didn’t experience relief you know what it might make sense to try
a new trial with HFX maybe you would like to eliminate the
tingling sensation that’s created in your current stimulator which you need
to get pain relief HFX could be for you or maybe your non-rechargeable device is
approaching the end of its battery life and you’d like to try HFX for your next generation stimulator
for those who don’t know spinal cord stimulation was first developed way back
in 967 and honestly for the next 40 years spinal cord stimulators only improved a little bit
as a matter of fact we used to tell patients that when we did a trial about
50% of them would get 50 relief and honestly we were pretty excited about
that level of relief we figured if 50 of your pain would go away we should try
this and a lot of patients went forward with stimulation but they just didn’t
get enough stimulation that really made enough difference for them
traditional spinal cord stimulators have other limitations many people dislike
the tingling sensation for example we call this a paresthesia and the classic
way that spinal cord stimulation used to work was by creating this ticklish
paresthesia type feeling in your back and legs but that feeling would block
the pain some patients just don’t like it traditional stimulators have other limitations
people typically need to turn it off when they’re sleeping for example or
when they’re driving and most traditional stimulation had significant
MRI limitations or restrictions how does HFX play into this equation
well HFX was designed specifically to address some of these limitations HFX is
a comprehensive solution to treat the complex dynamic and unique nature of your chronic pain
HFX is the most advanced spinal cord stimulator available offering a wide
range of benefits including its conditional approval it’s conditionally
approved for full-body MRI it eliminates the limitations of
traditional spinal cord stimulation for more freedom it offers the widest range of spinal cord stimulation frequency
and waveforms available and it provides individual pain relief to get people
back to everyday life HFX was first approved in 2015 and in
the early research the large senza trial which many doctors were excited about
when it was released showed that 76& of the patients still had pain relief at 24 months
HFX has been demonstrated to see to work significantly better and longer uh
lasting pain relief for chronic pain and leg pain than other spinal cord stimulation systems and it’s
been proven successful for people who’ve had surgery and tried other pain therapies next slide
so we talked about this a little bit but how is HFX different exactly well it’s
the most robust body of clinical evidence in any spinal cord stimulation system out there today
it shows significant relief for both back pain and leg pain when we first
started doing spinal cord stimulation we would tell patients this works pretty
good for your legs but if most of your pain is in the back it may not work for
you but that’s been eliminated with HFX HFX has been shown scientifically to
work for not only leg pain but also for back pain HFX offers programs without a tingling
sensation of that paresthesia that I talked about and that’s a big
improvement for many patients and HFX offers high frequency which is ten
thousand hertz but also low frequency from two to twelve hundred hertz and the
ability to pair these together which is such an exciting breakthrough that you
don’t have to choose one or the other high frequency or low frequency we now
have a device inHFX that can do both in the same device
and HFX has been designed for a 10-year battery life without program
restrictions and this is a huge advancement over existing technology
I just talked about how HFX works better for back pain but I want to show you the
science behind that there was a large study called the senza trial and many
doctors across the united states were so excited to see the release of this trial
and when the data hit we were all so excited that we would have options for
our patients that not only worked for the legs but also for the low back at
two years in this trial it showed that
back pain had 77% percent of patients that still had relief versus 49%
with traditional stimulation and with leg pain was 73% versus 49%
and so doctors across the country started confidently telling their
patients that we would put this system in to treat their back pain next slide
and you know what HFX doesn’t just work in large randomized controlled trials in
academic settings companies sponsored there was a large study done with 1600
I’ll say that again 1600 patients worldwide and this was done
just in your normal everyday doctor offices like if you came to my office
and what we found in that study was two years later 74 of patients achieved at
least 50% pain relief after two years so what that shows is this is that HFX
doesn’t just work in large academic institutions that you see on tv if
you go see your doctor and they do HFX this is going to work for you in that
setting as well and not only does it decrease pain it helps you throughout your daily life
HFX has been shown to help 72 percent of patients with their function 68 sleep
better and 90 percent report a better quality of life
HFX is the only system available that allows you to pair high frequency with low
frequency this is such an exciting breakthrough so if you look at this
chart it shows the other commercially available spinal cord
stimulators in the united states Medtronic Abbott Boston and Nevro and
what’s exciting about Nevro is it’s the only company available where you can use
this high-frequency stimulation that’s been shown to have such great effect for
the low back but then pair it with low frequency stimulation which still could
be better for some pain syndromes and also with burst stimulation which has
been researched heavily over the last 10 years and so HFX is the only one that
allows you to do all of this you’re interested you’re listening
you’re like dr lynch I think I’m pretty interested what do I do next well number
one is you got to talk to your pain doctor so talk to your doc and find out
if they offer HFX in their practice number two your doctor may choose to do
a temporary trial sometimes you can just switch the battery out and go straight
to the HFX battery we call it an IPG but sometimes you’ll need to do a trial
first and you’ll need to check with your doctor and see what your insurance requirement would be
and what their preference would be and then finally it’s the big day you
receive your battery and we’ll talk about this a little bit more later
in some of the questions but the the procedure is quite easy we just go in
we make one incision we remove the old IPG and we put in the new HFX IPG
so let’s get to a couple of questions how long is the replacement procedure
well I kind of touched on that before we like to say that it’s shorter than your
original implant because every doctor is a little bit different but I’ll tell you
in my practice it’s usually less than 30 minutes it’s one small incision and you
replace it and it’s usually done under just fairly mild sedation
the next question that we get a lot is does insurance cover battery
replacements and the answer is nearly
all insurance plans in the united states if they covered your stimulator
originally then they will cover a replacement next question is what is the difference
between rechargeable and non-rechargeable batteries well HFX has
a rechargeable battery and it’s designed to work for 10 years I’ll say that again 10
years it’s been approved for 10-year life without any programming
restrictions which is different than anything else on the market today
comparatively other spinal cord stimulation companies some of them make
10-year battery claims but at much lower doses or with other therapy restrictions
another question we get a lot is do all spinal cord stimulators deliver the same
waveform and frequency and the answer is no high frequency 10 kilohertz is only with
HFX and also unique to HFX is the ability to combine this high frequency
stem with other low frequency stimulation so you get the best of both
worlds in one device so I’ve taught you guys a lot about
spinal cord stimulation today and I want to just talk a little bit about my own
patients in my own practice we pulled data from over
200 patients that had this stimulation device and we tracked them over time and
we found that 34% were taking less medications we found
that 76 % almost right in line with the trial and the other published data 76%
achieve long-term pain relief 67% told us that they had improvement and function
and 62%  had an improvement in sleep and that’s what patients that I see every day it’s
such an exciting slide to look at to see how much of a difference we’re making in
the lives of these patients and I want to tell you about one patient
in particular, his name is Richard he’s a wonderful man he worked hard he had kids
at home and he hurt himself at work and his injury was significant and led to
chronic pain he worked all day and would just grit his teeth and work and do his
job as many of us do but when he got home at night he would elevate his knee
to keep it from swelling and he would take medications and he just felt
like he didn’t have enough time with his family and we did a trial and did an
implant and this was a quote from Richard that I wanted to read for you
HFX has been a life-changer for me I am hiking climbing ropes and running around
with my two girls who are thrilled to have their dad back I wanted to share
that with you because it’s so special to see these lives that are
changed by this life-changing technology so if you’re interested in HFX and
wondering if it might be right for you go to www. NervoHFX.com
or you can talk to your doctor about it and see if it’s right for you thanks a lot and have a great day