• What is chronic pain?
• Overview of your treatment options
• How does spinal cord stimulation work?
• Who is a good candidate for spinal cord stimulation?
• Clinical evidence & patient testimonials
• Insurance coverage
• Q+A with Dr. Bovinet
welcome everyone thank you all for being here today if you’re experiencing chronic pain and
you’re looking for a long-term solution you’re in the right place to answer any questions you may have
there will be a live q a with dr bovinay at the end of this presentation if at any time during the presentation
you do have a question please feel free to use the q a feature located at the bottom of your screen
next slide before i hand over the presentation to dr bovinay i’d like to quickly introduce
myself my name is kayla and i’m a team member at nevro we’re a medical device company based in
california and we’re hosting today’s session we’re the creator of the fda approved treatment option for chronic pain called
hfx hfx is an innovative and evidence-based treatment option for chronic pain that
includes a spinal cord simulation system and support services which you’ll learn about later today
and here at novo we’re exclusively focused on our goal to help more people living with chronic pain achieve
long-term pain relief and i’m happy to share that we’ve helped over 70 000 people worldwide find relief
next slide i’m excited to introduce dr bobine from
the georgia area who has taken the time today to speak with you about chronic pain your treatment options and share
his expertise dr bovine graduate graduated with a medical degree from michigan state
university and completed his residency and fellowship at virginia commonwealth university
he is double board certified in physical medicine and rehabilitation and pain management
he’s a key opinion leader in the field of neuromodulation in a spinal cord stimulation expert
his approach to pain management is to put together an individualized treatment plan that focuses on fixing the problem
rather than covering up the problem he’s driven by seeing amazing amazing patient outcomes individuals i’ve lost hope and
enjoys giving patients their lives back thank you dr bovine for being our host today and with that i’ll hand it over to
you great thank you kayla for the kind words
and nevro for hosting savannah this evening for everybody next slide
so here’s a brief rundown of what we’re going to talk about this evening we’re going to talk about what chronic
pain is um what spinal cord stimulation is and how hfx specifically is different from the
traditional mom-and-pop spinal cord stimulators you may have heard about or maybe even tried yourself in the past
and didn’t have great success with we’ll talk about why this is different we’ll discuss the clinical long-term
pain relief that people are getting in level one studies and the evidence behind that
what patients can expect from hfx we’ll talk about insurance coverage
who particularly is a great candidate for this procedure and we’ll open it up for questions and answers at the end
next slide so i just want everybody to know that if you’re on this call you more than likely
have chronic pain or you know someone that does you’re not alone um the here’s one you know quote at the
bottom that says 50 million americans have chronic pain other studies show it’s closer to 100
million people have chronic pain or chronic back pain specifically um you’re certainly not alone
in my pain fellowship 10 years ago we talked about with chronic pain comes fear anxiety and
depression you know your fear of doing something because it may cause pain you’re anxious
about doing those activities and then you’re just depressed because you can’t do what you want to do and
here’s some things i hear quite often in my clinic that you i’ve missed out on my family i couldn’t go to disney world i i
couldn’t walk my daughter down the aisle because i was hurting so bad um and they’re depressed because of this
this is common phenomenon this is what we see day in and day out i i tell
people my clinic i rarely save lives you know that’s usually in a airport on
an airplane or in a hospital or outside a hospital rather more in a in a restaurant i don’t ever want to do with
my clinic but improve quality of life every day to get your life back and with hfx it’s
one of those game changers in my practice i have been able to get people not only profound pain relief but get
their quality of life back next slide here’s one of my patients his name is
brian we didn’t get permission to use this in the past he’s he’s put this on there he had um never oh hf hfx
back then was called hf10 but this guy had chronic low back pain for almost three decades he told me he spent tens
of thousands of dollars on treatment options out of his own pocket above and beyond what insurance covered yes the
physical therapy the chiropractic care but acupuncture injections the epidurals
the ablations the trigger point injections everything you could think of he’s tried and more
he was sent to me and lost all hope until we did the never a spinal cord stimulator trial and we’ll get into that
a little later but the beauty of it is he got to try this first before he’s implanted with this device
and since that time he’s doing great here he sent us a picture afterwards he’s picking up this large
water bottle which he couldn’t even dare to do beforehand and he had said that life without pain is real life i rejoice
every day of being able to live my life so that was wonderful to hear that inspirational words from him
next slide so in my clinic we treat chronic pain and
occasionally it’s acute pain most of them it’s chronic pain and it can be challenging and everybody asks how do i do it um and it’s it’s rewarding when i see the great relief and like i said we get a lot of that with using the nate the number hfx
but typically with chronic pain we say either persist for several months or another definition is it persists
beyond the expected length of time for that to heal for example if you sprain your ankle it
might get better after you know two to three weeks at most if you’re still having ankle pain after
two three months well that’s not normal it should have healed by that so that’s a chronic condition now
so you know this is something that persists beyond the time you’d expect it to heal it’s generally several months despite
treatment or natural coping or healing efforts and if you’re recurrently injuring your ankles spraining all the
time that’s a different story that’s generally not the case but this chronic pain is going to be
different among individuals as it’s a basically it’s a subjective phenomenon
you know it’s a subjective experience that each patient you know experiences themselves with the pain there’s a few different
types we have you know the more rare type is the visceral organ pain when someone has like a gallbladder attack or
things of that nature that’s more visceral or organ pain there’s mechanical pain what we call
nociceptive the fancy word for musculoskeletal pain like if your knee or your hip hurts when
you stand and walk but when you sit and rest it’s better that’s probably a mechanical pain
and then there’s nerve pain it’s usually described as stabbing or sharp or shooting electric
and it can be associated with numbness and tingling the pain can come and go but most of the time it’s going to
always be there it might get you know a little better it might get a little worse but typically it’s always going to
be there okay and a lot of times positions aren’t going to have any effect on the pain there is a different
instance for example you have a combined mechanical and nerve related pain
you know many patients have lumbar spinal stenosis which is a mechanical compression of the nerves so you’re
getting a mechanical phenomenon causing a nerve pain so but for the most part typical nerve pain
is going to be constant and sharp stabbing burning electric shooting as opposed to an achy dull or tight type of
pain and as i said many patients do have mixed pain next slide
so nerve pain is usually a result of either nerve malfunctioning or misfiring the nerve signal because what a nerve
does it’s kind of like an electrical wire and it connects a part of our body to our brain and tells the brain what’s
going on and in return the brain tells it what to do whether it’s to move my arm or if you have a mosquito on your
arm to flick it away or something’s hot to pull it away so that’s what nerve signals do
but there could be nerve damage like if i didn’t pull my hand away from a hot stove or a hot fire i could have a burn
injury and it could damage those nerves and i could have nerve pain or if a disc continually presses on a
nerve and it’s not alleviated in time it could cause persistent nerve pain or if you’ve
had prior back surgery and now scar tissue has grown around
that nerve it could cause some nerve pain in that regard so it’s so there’s misfiring of signals
or inappropriate feedback to the brain telling you that you continue to hurt there
in the absence of any new problem going on so when that’s the case it’s really harder
to identify the source of that pain you know we might be able to pick out which nerve is problematic but we might not be
able to fix it so if it can’t be fixed well what do we do and we’ll kind of get into that a
little later as well but other things that can cause nerve pain above me on mechanical trauma or
heat trauma there’s also illness above and beyond injury and sometimes we don’t
have an identifiable cause and other times diabetes can cause there’s chronic illnesses as we said
diabetics can have diabetic neuropathy and cause the foot pain so something to keep in mind
but as i said earlier there isn’t just the pain that people experience
with chronic pain comes fear anxiety depression there is that physical component but there’s also the mental
and emotional components of the pain as well next slide so here’s kind of a treatment algorithm
or a pathway to kind of look at we always want to start at the simplest treatment option first and that might be medication so maybe you tried a
gabapentin or a lyrica or an eleval immitriptyline or an
anti-inflammatory tylenol you may have tried to lose weight start walking join the silver sneaker program or start
exercising your doctor may have sent you to physical therapy or to a chiropractor
and if those modalities work wonderful but when they don’t sometimes we’ll step our game up and try something a little
sometimes ablations which are usually utilized for more mechanical pain but that’s also in our treatment
algorithm when those therapies fail to give you any long-term durable relief we might
move on to hfx spinal cord stimulation this is something that help that pain that’s
refractory to those simpler things the injections the therapies the medications
and it traditionally we used to utilize this only after surgery had failed but now we’re seeing more and more often
we’re using this instead of surgery you know the nice thing is about the system you could try it first and see if
it works it’s not something that’s a permanent issue like surgery once you cut we say you bought the farm
what’s done is done we can’t undo it once you cut the bones away and put in screws and rods we can’t put the bone
back or put the tissue ligament everything back the way it was but the beauty is with these stimulators
as we’ll get dive into further in a little bit is we actually get to try it first to see if it works for you
another alternative is a pain pump which is a little bit different modality it’s also called intrathecal
drug delivery system where pain medications for example morphine are injected in the fluid around your spinal
cord next slide so spinal cord stimulation specifically
so what is it it’s a very well established treatment option of managing pain it’s been around since march of 1967
it was invented by dr norm sheely and the very first one that’s been planted in march 1967 his neurosurgical
resident was harold f young he actually taught me when i was in training in 2010 and i had the honor and privilege to
learn from him as well as many other attendings and hopefully we can impart some of that knowledge on to you today
but it’s been around as i said since 1967 so it’s 54 and a half years it’s been
around and it’s only gotten you know leaps and bounds about in the last six years since never has come along to the
united states for us um but it is a very safe option you know
despite the the 2020 reports we’ve seen in the past that doesn’t interfere with your normal
sensation i’ve talked to patients that basically what we’re doing you have this chronic pain for example in your back
and your legs you feel it in your back and your legs but it’s not your back and leg that feels it it’s the nerve signal
travels up via those electrical wires as nerves to your brain it’s your brain that feels it so we try and fix it we try and fix with
all those simple modalities we mentioned earlier the medications the therapy the weight loss
potentially an injection sometimes even surgery and we when we are unable to fix it well what
can we do to cover it up without doping up with pain pills because even when you start doping yourself up with with the
percocet or the hydrocodone your brain still knows you hurt it just makes it so you don’t care about that pain
okay so what we’re trying to do with spinal cord stimulation is stop or change that sensation of the pain
before it gets to your brain so you don’t feel it as much or if you’re lucky sometimes you don’t feel it at all
so but i tell patients you know a common question i get is they say well if i don’t feel the pain could i hurt myself
you know if i stub my toe i’m going to feel i’m like oh yeah you’ll still feel that you know you’re not paralyzed you can still feel your legs you can still
move your legs it doesn’t change that it just stops that chronic pain you’re experiencing from those nerves that have
been damaged or are still that that poor signal it changes that so you don’t feel that as much or at all okay so it’s very
gentle electrical impulses go to the brain um it stimulates behind the spinal cord
so i tell patients the spinal cord is here the wires and the fat behind it so it’s not in the spinal cord it’s not on it
it’s not touching it it’s damaging it or excuse me it’s not damaging it it’s in the fat behind it and it stimulates with
gentle electricity you don’t even feel um for the most part they’re using a high frequency stimulation that we don’t feel
it’s kind of like how dogs can hear things that you and i can’t hear it doesn’t mean that we’re deaf or dumb
it’s just such a high frequency our brains can’t perceive it this goes at such a high frequency at 10
000 hertz or 10 000 times per second and there are other frequencies they could utilize as well but the primary one is
10 000 times per second and that’s above our brain slope of perception so we can’t feel it and no dogs can’t hear it
don’t worry so but that’s really what we’re doing we’re changing that pain signal before it gets
to the brain so you can get your quality of life back next slide
so here’s a a brief table looking at some of the major players out there in the spinal
cord stimulator market some of you may have already tried some of these stimulators some of you may
have one of these stimulators or you have friends who’ve tried it or you have friends that hey i tried medtronic it
didn’t work for me or i didn’t like the way it felt i didn’t like that buzzing and tingling and that’s where hfx is
different as i said the primary waveform that they utilize is that 10 000 hertz and that’s
what’s utilized on the as depicted here in the top part of the chart you see the 10
khz the high frequency hfx from nabro is the only one that has that boston scientific abbott or or
formerly saint jude’s and medtronic do not have that option they could also utilize 10 kilohertz
pair to low frequency only with hfx not with boston habit or medtronic there’s a burst stimulation
where it’s on for a little bit off a little bit in faster than we could even say it kind of trying to mimic the
normal nerve firing patterns each of the companies can now do that but never was the only one that could
have a burst 10 000 hertz and then traditional low frequency is what most people have heard of if
they’re familiar with spinal cord stimulators before nevro or even from the other companies now
along with never they hear about the buzzing or the tingles that people feel and there’s a small percentage of
patients that do like that they do prefer that and i think that could be beneficial in those patients that have
that mixed pain that we mentioned earlier if you have a you have that neuropathic pain with the nerve related
pain that’s great for a stimulator but you do kind of have some mechanical pain that achy dull pain in your back just
kind of sitting there in an uncomfortable chair on the airplane you can’t quite get
comfortable sometimes it’s beneficial to have that low frequency option and never on hfx they could do that we
could have both you could have that 10 000 hertz that’s been shown to be statistically significantly superior
to that buzzing and tingling to help your back and leg pain but if you have a little that mechanical pain sometimes
having that gentle electric massage in short intervals might be beneficial so having the ability to do both
can be more beneficial than just having one option alone and as i said hfx and nevro is the only
device that offers the high frequency along with the low frequency and the ability to pay to pair those waveforms
next slide so other things people ask about
is after i get this i can’t get an mri is that correct i said no they have full body mri access
that’s been tested to be proven safe like the concern was previously that the the lead would heat up and it would
damage the spinal cord so i’m proven safe that it does not do that i’ve had several patients that had mris
directly over it after after the implantation because one for example had a he was involved in a motor
vehicle accident and he was still getting relief but he had new back pain around where the stimulator was at we
got an mri we saw something else going on so it didn’t inhibit that i’ve had some that have their spinal
cord stimulator in their neck helping out their arm pain and they get you know they need to get mri of their shoulder there’s there was
no issues with that either so the other advance you know benefits of
this as i said there’s more freedom with this you can have the tingles or that paresthesia if you want but if given the
option most people prefer not to have it so you don’t have to have it it is
safe to drive with it turned on and there’s no restrictions a lot of patience and fortune with the
traditional buzzing and tingling they’ll find that they turn it down so they don’t feel it so much because if you
cough you sneeze you bend you twist you look up you turn over you walk your dog
you’re going to get shocked and zapped i tell patients that think about your spinal cord it’s kind
of like my hand here and the stimulator when you feel traditional just that buzzing and tingling of traditional
stimulators it’s kind of like fire you know your about here it’s nice and warm it feels good
but if you get a little too close to it it’s too hot it’s uncomfortable when you get close and what happens is
you know when you extend your neck back for example it brings your spinal cord closer to
those wires you might get shocked and zapped and that that’s something we see in a common complaint an infection one
of the biggest complaints of traditional spinal cord stimulators there was the the senzus study
i’m sure most of you haven’t looked at that it might have bored you to sleep but as physicians we look at these these
level one studies where they can they basically control had this control study of a boston spinal cord team that had
patients complained that at some point in time with the boston scientific system that it was uncomfortable they
felt that uncomfortable buzzing and tingling and it hurt versus zero percent of never in that studies it was ever
uncomfortable you know the nice thing is since you don’t feel it we find something that works for you and we could
just leave it there leave that setting there as soon as we’ll adjust it so it’s not on as often to save the battery life
but usually you just leave it you don’t have to turn it off when you drive you don’t have to turn it off or turn it down when you sleep so it’s nice to have
those restrictions alleviated it is a rechargeable battery that’s you know good for 10 plus years
um and there’s no programming restrictions we don’t say that you have to turn it down and only use this much even though you might need this much amplitude or this much pulse width or these these all these different parameters that the rep and the
physician utilize to give to optimize your pain relief with your stimulator there’s no restrictions to take it down
to try and salvage your battery you’re still good for 10 plus years with this system next slide
so here’s one study showing um 156 patients that had an average pain relief
of seven point or an actually an average pain score of 7.4 out of 10 in their back pain
and there was a two-thirds or sixty-seven percent improving those pains percent of 2.4 which is
very significant and this is done by my colleague and friend dr capral um with
the 10 kilohertz hfx so after the hfx went from 7.4 all the way down to 2.4 and this is quite
fantastic what we’re looking for is not a 100 pain relief obviously we always love that for our patients but the goal
is 50 improvement and they far exceeded that as they’re averaging 67 percent in this study
so in the leg pain so back pain is one thing we also all have leg pain sometimes as well and these patients
another 156 patients the same source from dr capral they were on average had a pain score of 7.1 out of 10 before hfx
therapy and afterwards also down to 2.4 and this represented a 65 reduction in
their pain again significant is better than the 50 benchmark next slide
so here’s some more it’s it’s three studies here or three different sets of data we have
the hfx real world outcomes this actually has 1131 patients a huge cohort of patients
and looking at their most recent visit and what they were looking at is about 75 pain relief this is real world data
this is from patients just like all of you out there that may have gotten a spinal cord stimulator you know we all
love to see the published randomized controlled trials but we also want to see that it’s
replicated out in the real world we were able to see that with 75 reduction in pain from these 1 131 patients
in a two year long study the senza rct that i alluded to earlier those 156
patients they were getting around 76 pain relief on average even at the two-year mark which is fantastic
compare that to a traditional spinal cord stimulator and that same randomized controlled data again what we’re looking
for is 50 pain relief and unfortunately they didn’t quite hit that they’re about the 48 mark um still pretty good but not
at that 50 threshold that we’re looking for that we saw that the hfx far exceeded
next slide so things we get back to we get more
independence 88 of people with hfx are more independent because they’re reduced pain they’re able to do the things they
want to do whether it’s dance or walk their kids or grandkids down the aisle maybe just going to church you’re going
to get your hair done every friday like my my mother-in-law does um 68 of patients reported improved quality of
sleep and just sleeping better your pain is going to get better you have that stress
hormone cortisols released when you have that poor sleep which can make you a little frustrated and more anxious so
when the sleep gets better because your pain is better your mood is going to get better we do that we improve your
quality of life and what we saw was 90 percent of people are showing they have improved quality of life
and four out of five people give the good old thumbs up and they’re experiencing meaningful long-term pain
relief you know and they would recommend this to their friends next slide
overall in my practice what we’re seeing is 31 reduction in pain medication usage
these are patients that put the stimulator in most have already had had prior back surgeries and on pain
pills for years and what we’re seeing it is 31 have reduced their pain medication we saw 77
have achieved long-term pain relief um 80 of them or 4 out of 5 reported
improvement in function and this is across 150 patients in 81 a little over four out of five are
also reporting improvement in sleep so we got pain relief reduction of meds improvement in function improvement of
sleep i call that improvement in their quality of life next slide
so what is hfx an option for so traditionally we use it for back
the trunk leg or arm pain that has lasted over six months if we said chronic pain
that’s failed conservative conservative therapy so it seems to be debilitating pain a minimum of 5 out of 10 on the pain
score even if you’ve tried surgery or not but at least have tried physical therapy or
chiropractic care do some home exercises or physician-led exercise program to do
some medications unless you’re completely averse to those which i have those patients too
you either are not as a candidate for spine surgery or you don’t want it sometimes patients come in if they had
an overt foot drop and there’s an obvious disc pressing on the nerve there’s a there’s a small surge that
could fix it go ahead and do that this is more traditionally for patients where there’s no obvious surgical lesion
there’s nothing that surgery could fix or you tried surgery and it didn’t work or if the patient just doesn’t want
surgery or they’d rather try this first then you could be a candidate for this
you’re also again if you want to try and decrease or avoid pain pills altogether so our ideal candidates are the low back
pain patients it used to be back and leg but now what we’re seeing is a lot of patients have just back pain
with traditional stimulators with the other companies i would have never offered spinal cord stimulators for isolated back pain because it didn’t
work after the first 150 patients i did and i think now with never over
three probably 400 patients out of the 1400 siblings i’ve done over the years
but this is from the only one i use now um since it came out 35 of my patients were low back pain
only and as i said i never would have done that we’re seeing in the mid 90 success rate with those it’s fantastic
for that for foot and leg pain as i said there’s a recently published article
in the new england journal of medicine neurology section talking about diabetic peripheral neuropathy and helping foot
pain if you have knee pain that we think is is nerve related pain if it’s mechanical
it hurts when i stand it hurts when i walk but that’s it and it’s achy and really arthritic it might you might
not be a candidate but if the knee pain never goes away it’s sharp and stabbing it’s always there whether or not you’ve
had knee surgery if you’ve had any surgery and sometimes you could have this persistent
nerve related pain because of the surgery you’d be a great candidate for it same thing for the hip
also arm and hand pain the stimulator can go safely in the neck as well and help arm and hand pain
it can’t help growing pain sometimes people have that persistent pain in the groin after having you know
either hip surgeries or if they have other other types of surgery in that
area and sometimes from the mesh placement they could have that pain and obviously
sciatica and leg pain and generally get good relief with this system next slide
so typically what you do if you want to you know move forward in the hfx process
is talk to your provider and see if they do offer hfx or you can go to the navra
website hfx and and look to see if there’s a provider area that does offer it and
they can assess your condition and talk to you and answer any questions see if you are a good candidate for
hfx scs um like i said the best part about this system is you do get to try it i i set
up two patients today in my clinic you know one had already had prior back surgery actually
three prior back surgeries and didn’t want a fourth and wanted to try this and the other was an 85 year old young
lady that didn’t want to have back surgery she said at 85 she didn’t want to try that but she was ecstatic wanted to try
this she looked at a poster i had in my office and she said she wanted to try that before i walked in the room but
after reviewing a chart and seeing that she had failed multiple rounds of medications injections from multiple doctors
including myself and uh in physical therapy and chiropractic care i thought this is a great option
for us you guys get to try it and that’s the beauty of this system you do get to try it for a week i tell my patients
just like if you’ve had injections they put a little needle not the size of this pen it’s much smaller than that um but
the size of the metal part of the pen but just like you’ve had an epidural in the past they put a needle in you they
squirt medicine to pull the needle out same type of thing with the trial we put a needle or two in there but instead of
putting medicine and we put a little flexible wire in through that space and i said it gets into the fat behind your
spinal cord not in it on it touching it or damaging it it’s in the fat behind it and we pull that needle out
and the way i do it i secure it to your skin with fancy bandages without cutting or sewing and you try it for a week
that’s what i do to my clinic seven days long and you find out see if you can stand longer walk longer be more active
see if you can sleep better see if it could improve your quality of life at the end of the week if you really like it as long as it helped a minimum of 50
percent usually your insurance will pay to put in the permanent one i honestly tell my patients if you’re not sure don’t get it
if you’re not fully convinced it’s great you got to try it out it wasn’t great don’t get it i haven’t really seen that
was an issue if you’re one of the rare patients where it doesn’t work great for obviously those little wires come out
you put a band-aid on cover the little poke hole you’re right back to where you are today no harm no file no better but
no worse so if you go through the trial and you love it it works great you improve
function improve quality of life everything’s great you get implanted it’s a minimally invasive surgery
where those little wires when you’re back and they’re secured to the ligaments of your back and then tunnel underneath the fatty
underneath the skin and the fat of your back and put a small battery kind of like a pacemaker for your spine okay you’re not
feeling it just like you’re not feeling the pacemaker it’s not controlling your spine just stopping that pain signal from getting
to your brain though so it’s typically an outpatient procedure which means you go home the same day so
it’s usually a 30 minute to one hour kind of minimally invasive kind of micro surgery i tell my patients if i do it i
have two small incisions one about an inch long where the wires go in and one about an inch and a half long
and the fat of your back where i put that little batter and make a little pocket and put that battery in there and when i
do it you’re not cutting muscle you’re not cutting bone you’re not breaking bone you’re cutting skin you do feel that so we do give
sometimes some pain pills for that or you could ice the area and then fat which you don’t feel because there’s no
nerve pain fibers in there that are significant okay because we’re staying away from the muscle in the bone itself
after that implant procedure a lot of people experience pain relief right away some might take a few days or we might
need to program adjust the programs to find the right settings but we try and utilize the same settings that work
great for you during the trial we do that for the implant procedure sometimes you’re putting a back brace
for a few days or up to two weeks or so to try and prevent you from moving around too much i usually do that for my
patients just you don’t pull on an incision i want you to pop a suture i’m not really worried about the leads
moving too much that’ll also help make sure the leads don’t move initially it’ll help you heal well
and also having the pressure from that back brace you’ll feel that into that sharp incisional pain from those small
incisions to help decrease your pain and decrease your need for any pain pills for that post-operative period
next slide so here’s the system components
okay in the top left we have the trial stimulator battery that’s with the little wires that we see on the right
picture the top right that’s what they’ve been inserted into what’s sticking outside your body
usually it’s in an adhesive pouch that’s kind of stuck to your back so it’s not inhibiting your activity so the wires in
your back the way i do it is secured with bandages they stick out they go into that trial stimulator battery and
that’s an adhesive pouch stuck to your back so nothing’s in your hand when you’re utilizing that
in the right picture that’s the leads in the permanent battery there okay so if the trial works great you love it you
want to get it planted those two small leads are 1.4 millimeters wide so really tidy so for a lot of people it’s a
little bit the white part on the tip your nail there unless you have really long nails for
halloween or something but that’s usually what they are and then that battery is inserted it’s like
a stack of a couple silver dollars okay the bottom left picture is to charge you
that blue rubber soft disc so my patients you charge over the top of your clothing so so after you’re implanted
you know everybody’s different a lot of we adjust the settings you charge once every six days some people charge once a
day um hasn’t been much of an inconvenience for anybody because most people are charging their smartphones
for all night long or three or four hours most people are charging minutes i say while you’re sitting down
whether you’re sitting in an easy chair watching the news reading a paper you know watching your stories at night
or eating breakfast eating dinner just put that against your back sit back without holding it
or if you want you can have a velcro belt hold it you can walk around but it charges that battery via bluetooth just
like the people the fancy phones they can put on a pad and charge it same thing it’s not plugging into your back
there’s no wire sticking out of your back it’s charging via bluetooth just to get bluetooth in your car but it charges
over top your clothing through the skin to the battery okay and then on the bottom right you see the
all or about once a week at most and that’s probably about 85 percent of my patients most people hide it in a sock
drawer somewhere because we find settings that work for you and then we leave it alone next slide
so here’s a few questions we’ve been asked quite often that we wanted to put in here some people ask can i turn the device
off and yes with that remote control you do have the option to turn it off most people don’t do that it’s not
really needed but you can turn it off if you like some people ask about flying with their if they can walk through a metal
detector yes you can fly once the doctor says you’re cleared from a post-surgical standpoint um i had one patient that
didn’t believe me as far as the metal detector so after we did her trial she walked over went to walmart and
walked out and hoping she’d set the alarms off but she didn’t um so yes there’s no interference with that either
otherwise they could swim so during the temporary trial because the wire is sticking out of your back you can’t swim
or submerge underwater during that time i usually have my patients wait about two weeks
after a permanent implant before they go swimming i want to make sure the wounds are are fully closed fully healed up to
make sure everything’s good okay some people might put skin glue on there might
change that but usually most people are waiting at least two weeks before they have you swim but yes you can swim afterwards
other people say health will need to recharge my battery here it says charging really takes 45 minutes most of my patients are less
than that 20 to 30 minutes um some people do it every day just so they don’t forget but i have a lot of
patients that are doing it once every six days instead as i said while they’re watching tv or just plugging in while
they’re driving or eating eating dinner or breakfast just anytime you’re sitting is a nice convenient time to do it
next slide as far as insurance coverage we’ve seen
great coverage with for hfx in our area here in georgia it’s covered by medicare aetna humana
united healthcare blue cross blue shield tricare we’re seeing great coverage so you can talk to your provider and see if
they offer this therapy and they can look at your individual insurance and see if it is covered
most states medicaid policies also cover hfx workers comp in all states except for
the state of washington covers hfx and there’s a lot of va’s who are now offering hfx and some of those patients
i i don’t work at a va hospital anymore but i do have a contract with the va clinic where i’ve had patients
specifically sent to me not just here locally in georgia but also some from actually richmond virginia were sent
down to me to offer this to them so yes va’s are offering it as well
next slide so ask the questions your provider to see
if this is right for you you know as we said ask if they offer hfx ask if they offer navro specifically
are you a candidate for this you know and ask them specifically what’s the treatment process like
more than likely to be pretty similar to what i discussed tonight but there might be some deviations in how they do it um
you also ask is it safe and it is we’ve looked at a study um a previous study i looked at for some
nerve related pain they were looking at medications like gabapentin and lyrica and they they talked about the number
needed to harm which is an interesting stat because how many people need to be treated with something before
unfortunately one person is either harm an adverse event of an infection bleeding or something of
that nature the number needed to harm for gabapentin is only 1.6 that means
for every 1.6 people treated with gabapentin one is going to have a side effect from
that or harm from it for lyrica or pre-gabalan’s 1.8 in that same study i saw the number
needed to harm for spinal cord stimulators was 128 that means 128 people are
treated before one person has something that might be lead migration or an infection something like that
i haven’t seen any paralysis or nerve damage or anything like that in my clinic
so those kind of things are exceedingly rare and i don’t know anybody that has done done that at all so um but i’ve
heard patients asking about that so i thought i’d bring that one up um possible side effects they said
infections like that occurred like with any surgery um it’s less likely than the bigger surgeries that the more
invasive the surgery is the bigger the scar or the bigger the surgical site itself the longer the time of implant
the increased risk of infection simply it’s it’s two to three percent unless you’re a poorly controlled
diabetic or a smoker it might be in the published literature higher up to five maybe eight percent um
in the lumbar spine i haven’t had any infections like when i’ve done them um so it is pretty low risk in that regard
some people have pain at the battery site about one percent of people usually in very very thin people i’ve put it in
patients as thin as 78 pounds some 88 192 pounds those are the difficult ones
but for most patients there’s no problem finding a place to put that small little battery it’s a little bit thinner than
my pinky okay how much pain relief should you get well the last time we pulled the data to
my patients what we saw after the trial we saw about you know well into the 90 success rate
as far as patients with the trial um and on average you’re getting around 78 percent pain relief the goal is 50
that’s what you should expect but we always hope for more okay how long will it last we hope
indefinitely you know some companies some stimulator they say that sometimes you can get used to the stimulation it
doesn’t really work and that’s the beauty of hfx there are so many different treatment programs with the
new battery there’s 35 different combinations of programming we could do to switch up to find something that
works for you like i said most people are just utilizing that that high frequency or it might be
cycle where it’s on off or maybe you know paired with another frequency there’s many different options we could
utilize if one for whatever reason stops working or if you have a new nerve pain
that we weren’t initially treating then now we need to cover that’s in that area we could adjust and reprogram if needed
and yes as we said the hfx is covered by your insurance for most patients anyway i would talk to
your provider and their billing department by your specific insurance next slide
so i see there’s already several questions here um
let’s see we can take a look here do a minority here um um yeah i can hop in actually dr will
maybe help you out a little bit and uh kind of feed some of these questions so uh first of all thank you so much for
sharing your knowledge and expertise with us we love to open the floor and answer any
questions anyone in the audience has about chronic pain spinal cord simulation and hfx so if you do have any
questions just go ahead and use that q a feature located right in the bottom of your screen and we’ll just go ahead and
dive in so dr bovaney we do have a question here someone is wondering if they get hfx are
they still able to see a chiropractor and get care from a chiropractor
yes i allow my patients to the chiropractor immediately post properly i’d say i’d wait a few
wait a few weeks on that you know they could adjust in other areas for example if i implant in somebody’s neck i’d say
you could adjust their back the lower back but give me a few weeks before we we mess with the neck um and then maybe
not too vigorous of cracking and drawing the neck too much if i same thing if i
do it in the back the neck is okay to work on but let’s let’s hold off for a few weeks to ideally probably six weeks
before we start doing anything the leads we want to scar in place i do anchor them in place i sew it down to
ligament make sure it’s nice and tight and held in place but a lot of times a little bit of scar forms and really holds it i want to make sure those leads
don’t migrate um but yes i do allow chiropractic care after hfx therapy
um you know speaking of the neck area does hfx help with neck pain
it does it’s not and so i’ve treated several patients with neck pain um
i have probably done about 75 patients with neck and arm pain usually you have to have extremity pain with it you know
it does help the neck but usually we can’t do with neck alone you need to have that arm pain with it there is this
senza uln study that looked at that it’s the upper limit next day we’ve got about 42 patients in there to 91 success rate
i’m personally a little bit better than that i have like i said 70 patients and i have 100 success rate in that
everybody’s gotten at least 50 pain relief i did have one patient that didn’t go to permanent implant he said
it helped a hundred percent of his neck and his arm pain except for his hands only had 50 relief but he also had
carpal tunnel syndrome um and we think that’s what was causing it he did get the carpal tunnel surgery
but then because of cobain i haven’t seen him back but we may reach out to him to see how he’s doing to see if he needs that but yes it can help neck and arm pain i’ll piggyback i saw one question about trigeminal neuralgia kind of an
off-label thing but what i have seen um when we throw it up high cervical really
high up in the neck it it can do well so the traditional nerve we have the v1 v2 and v3 division you can see my face here
there’s the three divisions it most of the time it’s hit or miss and we get the v1 division but v2 and v3 so around the
eyeball to like the mouth we can get pretty well and the mouth down we can get pretty well is what i’ve seen but
that’s anecdotal that’s not from navro that’s just my own personal experience
kind of talking a bit about like more like who hfx is for does it help with like lumbar stenosis for example
it can help with that so they said lumbar stenosis kind of a mixed pathology is a mechanical problem but it
causes a nerve pain okay that’s where a lot of people get confused in that so
some of my patients if they’re not great candidates for spinal surgery to decompress it whether directly or
indirectly in a minimally invasive or a maximally invasive fashion um some have
opted to try stimulators to the point where my reps say oh that’s not going to work it comes and goes but he was
completely surprised to see that it worked and it’s still working years later so it can work for stenosis because the
as long as they have a neuropathic component to it you know even though the pain does come and go uh if they feel
like they’re having the nerve component of it if it’s just they lean back and they feel that achy pain in their back
and they happen to have stenosis on mri probably not but if they stand and walk and they have
a lot of back pain with that that does radiate down their legs hips thighs or buttocks you know that is a nerve issue
from the stenosis and it can benefit that yes okay so then what about fibromyalgia
pain does hfx help with that type of pain fibromyalgia specifically no okay a lot
of times patients with fibromyalgia will also have a nerve issue separately i mean
fibromyalgia is kind of like a a hyper excitability of all your nerves
and you kind of hurt in all these musculoskeletal areas but sometimes they’ll also have sciatica on top of it
so yes it could help the sciatica component and yes it could help your sleep which
is a big part of the fibromyalgia syndrome and yes it might help your mood because you’re sleeping
your pains better but directly treating fibromyalgia no it’s not indicated for
that i’ve seen it anecdotally help that but just because we were focusing on
something that the stimulator is specifically intended for that it helped and secondarily the fibromyalgia
symptoms got better because they were able to stand and walk boring but there was a study august
oh august 18th of 2010 in the new england journal of medicine saying the best treatment for fibromyalgia is not
all the pain meds out there not the lyrica’s the sabellas the cymbaltas or your percocet or morphe it was actually
tai chi or aerobic exercise so i think that for those few patients that had the
fibromyalgia that happen to have you know back and leg pain from failed back
surgery or chronic nerve pain that i did a stimulator on they did well with that because i got them moving
more and more active i think the fibromyalgia got better as a byproduct sorry for the long-winded answer
got it no no i think it’s better to hear the full story right so okay so what about like crps for
people who have that could this potentially help absolutely so the two main indications that will always get
approved by your insurance doesn’t matter what insurance you have it seems like is prior back tailback surgery
syndrome or lumbar post seminar to pain syndrome and complex regional pain syndrome or crps or something called rsd
reflex sympathetic dystrophy or cause algae there’s many terms out there but that is just the quintessential nerve
pain that is you know pain out of proportion to stimulus you have all these nerve issues but yes that does well absolutely
and what if someone has neuropathy like in their feet and in their lower legs could they find pain relief with hfx
yes traditionally that was something very difficult to treat we’ve done it over the years
kind of off label there wasn’t that indication in the past for it but anecdotally we have done that but
sometimes when patients already have you know pain and tingling in their feet or it’s numb and tingly why would i want to
give them more tingles with the traditional stimulators the benefit of having the hfx and not
having the tingles or not having that paresthesia we have found great benefit
in that and in nevro with hfx recently published a study and they get a new
indication for you know painful peripheral neuropathy diabetic neuropathy so i’ve had some patients
that we’ve done for that have done very well but traditionally in the past the foot was the toughest thing to get and
it’s still hard but but never hvx does a great job with that better than i’ve seen with any other company
we have a couple people in the audience who are currently implanted with another device so someone has an abbott someone
has a boston and they’re wondering can they you know is this an option for them even though they already have a
simulator yes i another patient today i talked to about a student she already
has a boston scientific and she said it used to help um i think she said 70 80 during a trial
and then it went down to like 60 she’s a a patient my former partner that has moved on so now i i inherited this
patient and you know she also had some mechanical pain which we took care of in her side joints but now she’s like you
know feels like it’s only helped about 25 she’s been reprogrammed with all the options that boston scientific had but
it wasn’t helping especially her feet she got awful neuropathic pain at her feet
so what i’m doing for her is you know because she can’t get an mri with her system you know if she would
have the never hvx she could get it i have to get a ct scan but i’m going to get a ct scan look at her spine because
she had a more involved surgery to put that system in and look at where the leads are at
and i’m going to just get a plain extra thoracic spine and see where the leads are at and see where they’re entering their spine
if they’re well above the target that i need to be to treat her back leg and feet i’m just have her turn her boston
scientific system off you know let it not you know for like a week or two to make sure it’s not working or helping at all and then trial
never a system below it put two brand new wires below it you know sticking out through the scan
with an external battery and she would try that for a week and if it works great she really feels like it’s significantly better
and it helps you know the back and leg even better and it actually really helps the feet unlike the boston system you
know we could take out the one and put in the other system other times or alternatively if it
happens to be that her stimulator you know she actually had a paddle placed instead of just the two little wires
that i put in but if that paddle is covering where i needed to stimulate where the hfx works the greatest at
which is usually slightly lower than other companies but there’s now they’re starting to after all the data’s come out with netro they’re starting with
their leads a little lower like nevro and hfx is doing um but if they are covering the sweet spot
i may be able to just if she wants to do it i could swap out her battery take the boston out and then put in the never a
battery the only issue with that is she probably because i’m if i only swap the
battery she won’t be able to get an mri because of her boston leads if we take out everything put everything in brand
new she would be able to get an mri but as it stands today she can get ct scans
what if someone has pain in multiple locations can one implant help or would they need more
than one you can have one like if a patient has neck and arm pain and back and leg pain
what i typically do because the trial that there’s a chance the leads moving even though i struck my my patients try
not to bend way over twist way around or lift way overhead you know to prevent those leads from
moving but still walk and be active the best you can sometimes those leads move so to try and mitigate that risk i’ll
put in two leads so i’ll put two leads and i kind of stagger them so they kind of look like this here
you know whether i do that in the neck or i do it in the back so it’s in the neck it’s to help neck and arm pain and occasionally that trigeminal algae we
mentioned earlier um or just back pain or his back and leg pain i’ll have those leads staggering kind of covering where
i need to cover whether it’s both sides of the midline or if it’s just left to go midline and to the left
we’ll optimize where we need to be we’ll figure out where we’re stimulating at and then i’ll do the same thing for the
other area and then i’ll put in one lead in each only utilizing the lead we’re actually
stimulating on and then they can be anchored in each place and hooked up to one battery
technically if you have two leads in both place you do have more options because they can kind of have
they kind of talk to each other if you will or like bipole you do have more options but it’s not
absolutely necessary i have several patients you have one lead up one lead down hook it up to one battery
and we have some questions here about recovery could you talk a bit about you know how long after the implant can
someone return to work like what does recovery kind of look like so i usually do my surgeries my implants
on wednesdays and patients easily go back to work on monday not a problem you know
um so they’ll be sore so i do one patient asked about anesthesia i don’t do any
general anesthesia just iv sedation you know for the trial we do give sedation most of the time i have a lot of
patients that don’t want it one of the ones i ordered today he said my wife doesn’t drive do i need a driver
about 10 percent of patients i don’t do any sedation for for the the test procedure i just numb
it and do it a lot of people say a lot of people need sedation for that is either an epidural i do recommend it for
most that way we know that you’re laying still but it’s usually just iv sedation
so um for the permanent implant again i choose iv sedation and i numb the heck out of it okay so i numb a lot but it is
a little micro surgery like those two small incisions to put it in and we do sew up i close in two to three layers
depending on the the wound itself um and so you’re gonna be a little sore from that you’re a little sleepy from
the anesthesia itself so no driving because you’re the under the influence of those meds that day i
typically give people like 16 to 20 pain pills some people don’t take any at all some people just take tylenol some goes
to ice the area so we soar for a few days i tell people again for two weeks limit
your your blts the bending lifting and twisting i recommend they wear that back
brace and one thing i also do i have them take a washcloth
you know fold it in half and fold it in half again so kind of looks like this and put over the incision and put the
back brace over it to hold it in place and then they’ll feel the pressure from this just gentle pressure like you’re
putting your hand on your leg as opposed to that sharp incisional pain so it helps decrease your post procedure
pain it also prevents fluid from accumulating in that wound so it makes it heal nice and flat so it looks
prettier and also heaven forbid fluid does fill up in there that’s a nitis or a nest for infection so they said i’ve
had zero when i’ve done these these lumbar stimulator implants and i don’t want to start having one now so
the other thing is i don’t have people shower until saturday so i do these on
wednesdays typically i say shower and saturday if they want to go back to work on monday some people if they have a
desk job a sedentary job if they’re not taking pain pills they feel like they’re clear-headed some will go back to work
on friday but they say usually wait till monday if you have a more physical job a more
demanding job you want to wait a few weeks to make sure that wounds are fully healed we don’t want you to pop a small
little wound open or pop a suture we are getting close to the hour but i
do want to get in a few more questions so if anyone has any more questions go ahead and feel free to
enter them now so what if someone has a pacemaker is this an option for them
yeah they could still get that there was a paper i think in 2013 that came out that showed that it was safe when i when
i came here to practice in georgia there’s a lot of patients that couldn’t get it but i usually do eight to ten patients here that have a pacemaker or a
defibrillator you know we always run it by the cardiologist you get clearance and initially they’d have the pacemaker
rep here they always did that now they say no yeah it is safe so usually they’re not here but typically what most
of the cardiologists in the area do the day we implant them they’ll set it up and they go straight to their clinic
and they’ll interrogate the pacemaker make sure there’s no interference usually the leads from the stimulator
are far enough away from the pacemaker or the pacemaker leads but there’s no interference whatsoever
sometimes because the pacemaker some companies you can’t get an mri um and some you can so
some will have the you know we’re gonna have the combination with pacemaker and the hfx simulator and they could still
get a meris and there’s no interference with that in one
got it and um would this help with someone who i mean
or is this an option for someone who has like rods and screws in their body like can they still get hfx
um absolutely so most of my patients that get stimulators already have rods and screws if you still have you know
back you know or or leg pain because of that you know just because you have rods and screws that mean you have pain but if
you’re having what seems like neuropathic pain if your pain is always there i tell my patients the best ones
are the pains that are sharp stabbing burning electric the pain never goes away it might get better or worse but it
never goes away you know and if it ever wakes you up at night that’s awful for you but it’s amazing for a stimulator because that’s
definitely nerve related pain but if you could you know get to a certain position the pain goes completely away the
stimulator might not work for you like those cases stenosis you can lean forward or sit it gets better the
stimulus still can work for that but the ideal stimulator candidate the pain never goes away it’s either sharp
stabbing burning electric shooting um in any if it wakes up at night even better
thank you well you know we are a little bit over the hour and i want to be cognizant of everyone’s time so you know
thank you dr bovinet for answering all those questions thank you for everyone who took the time to join us today i’m stephen could you
go ahead and move to the next slide so before we do end the presentation i did want to share some next steps and
resources for everyone on this call if you’re interested in learning more about hfx we encourage you to explore
our website at hfx.com it’s a great place to start your research you know there you can find information about how
hfx works to manage your pain and what to expect with hfx i also highly recommend to visit the patient story of
section of the website you know for a chance to hear real stories for real people who have actually found relief with hfx on our
website also you can take a short questionnaire about your pain to find out if hfx could be a treatment option
for you and if you provide your phone number we’ll assign a hfx coach to reach out to answer any questions you have and
help you locate a physician near you who has experience with hfx or if you’d like to talk to a physician
sooner you can just go ahead and hop on our website you can use our physician finder tool to find someone near you you
know dr bovinet is in the georgia area and if you’d like to see him you can just pop on that position finder and
find his information there again thank you for your time today dr bovene and thank you for everyone on the
call i hope you enjoyed the presentation and have a great rest of your day
