SCS questions

[Tapspatellas]

Check out all the studies that are done on BurstDR and HF10 besides the Senza and Sunburst study.

If you have a thought of using two systems with an option of tonic then Abbott with BurstDR and tonic fits.

Supposedly Senza tonic is not great.

Burst other than BurstDR is cluster tonic and does not light up the medial pathway. This was studied

HF10 is only used with Nevro. This was Studied

1k,4K, 7k, 10k was studied in the Proco study.

Whisper study was very lacking.

Now when you talk about randomness and something not studied well at all then go ahead and try something like targeting multiple stimulation patterns at a time.



I don’t care about these companies but I do care about OUR field.

When we fall for gimmicks and not research at this point then we are taking steps backwards.

They are all gimmicky, that is what sells. You can’t just buy into it, but . A lot of this sounds like what the Abbott reps say to me.

I don’t think they’ve proven that the fact their burst doesn’t fully repolarize matters in outcomes, just “mimics neuronal firing”. Sounds good but sounds like a gimmick too.

Medial pathways, sure it makes intuitive sense but does it matter? All the fMRI studies I take with a grain of salt.

The SUNBURST study showed crappy endpoints for both their tonic and burst patients, less than 50% improvement in VAS at 12 weeks. Wouldn’t even qualify for an implant if they weren’t already implanted. I’d hate to see them at 12 months... if anything this made me not want to use Abbott.

SENZA was great, I can’t say anything poorly about someone using me to based upon that study. This is the “best” device on the market from a study standpoint at this time, in my opinion. But again, older system was compared with substantial change in the software in pretty much all competitors at this point. Not studied against so it’s hard to say it matters, but I believe that there is a substantial difference in the software.

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[epidural man]

. This is the “best” device on the market ....

Not if infections rates are super high - and the company is trying to hide it.

 

[lobelsteve]

Not if infections rates are super high - and the company is trying to hide it.

Do you have evidence to that end?

 

[Tapspatellas]

Not if infections rates are super high - and the company is trying to hide it.

“Sticky” materials? I imagine the can is similar to everyone else and should run no more than the 3% that I’ve heard as the “acceptable” rate. Dirty fingers messing around back there with the increased charge burden while healing? I thought they asked to leave it off until healed. I agree with Steve, I’d have to see the actual evidence of the infections to definitely believe it. I’ve always assumed that device manufacturer had no impact on the infection rate.

 

[epidural man]

Do you have evidence to that end?

Nope.

But I am saying, IF they have a higher infection rate (and they might), then regardless of outcome on a non-infected system, it would be difficult to classify them as the best.

 

[drusso]

Burst other than BurstDR is cluster tonic and does not light up the medial pathway. This was studied

When we fall for gimmicks and not research at this point then we are taking steps backwards.

Modulating the medial pain pathways is the holy grail for our field...electrically reversible frontal lobotomies...

 

[lobelsteve]

Nevro is aware of an online synopsis made available by the private news source FDANews (which is not affiliated with the FDA). There is no merit to any suggested implications of this summary as it mispresents Nevro’s excellent quality record and reporting policies. Importantly, the FDA has conducted a subsequent inspection in March 2018 and had no findings related to this matter, further supporting our exceptional quality record.

In October 2017, the FDA performed an inspection of Nevro’s corporate facility in Redwood City, CA. As part of this inspection, the FDA asked Nevro to respond to questions regarding Nevro’s complaint reporting policies and procedures. These questions focused on infection-related complaints that represented approximately 0.4% of all implanted Nevro devices.

To provide broader context, a thorough search and analysis of the 2017 MAUDE Database (where complaints from manufacturers are reported to the FDA) was performed. All manufacturers report infection-related complaints based on their own reporting policies. As represented in the following chart, all manufacturers’ rates of reported infections fall within a range of ~2.0% to 5.0%. In performing this analysis, we included a broader set of complaints, and even with those additions, Nevro’s rate is at the lower end of the reported range seen across the SCS market as represented in the following chart:

*Internal data on file, based on US estimated sales and 1,759 MDR reports across the four manufacturers

Nevro remains committed to transparency, safety and superior outcomes. In reviewing all internal and publicly available data along with the significant body of long term peer-reviewed literature, Nevro device infection rates are among the lowest of all SCS manufacturers.

 

[gdub25]

We tout studies when it helps us but ignore studies or lack there of at other times.

Wavewriter may have some real world experience but does it have any evidence as well?

I would advocate to anyone to use the companies with level one data for wanting to expand our field of Neuromodulation.

If other companies see that this matters to us then they won’t throw out gimmicks to catch our attention.

Gimmicks are good sometimes but we should demand more right now.

We have new waveforms/pulse trains, targets.

Companies like Mainstay and Saluda doing are doing reasearch as well and may disrupt the space soon.

Check out all the studies that are done on BurstDR and HF10 besides the Senza and Sunburst study.

If you have a thought of using two systems with an option of tonic then Abbott with BurstDR and tonic fits.

Supposedly Senza tonic is not great.

Burst other than BurstDR is cluster tonic and does not light up the medial pathway. This was studied

HF10 is only used with Nevro. This was Studied

1k,4K, 7k, 10k was studied in the Proco study.

Whisper study was very lacking.

Now when you talk about randomness and something not studied well at all then go ahead and try something like targeting multiple stimulation patterns at a time.



I don’t care about these companies but I do care about OUR field.

When we fall for gimmicks and not research at this point then we are taking steps backwards.

I love reading posts like these two quotes above, laying truth out there. This forum always wants to talk about studies and evidence based medicine and sometimes I shake my head when I see arguements that are pro Wave Writer, Intellis, HD/tonic at the same time, etc. Can we all quit being friends with the reps, listening to the reps, even talking to the reps and just follow the level 1 studies readily available. From there we then can go to the lower quality studies, critically review them for ourselves and draw our best conclusions. This is the practice I try to live by and in my opinion the choices are easy to make.

I’m pro Nevro, they have the best evidence and long term outcomes by far, have done level 1 studies on low back and leg twice in two different countries with many enrolling sites and achieved the same 24 month outcomes in both. They have an ongoing neck and upper limb study with outstanding prelim results so far. They have many other single center studies with relatively good sample sizes that are good for at least some insight. I love that they’re committed to putting their money where the mouth is.

It seems all the other companies have a target on Nevro’s back, trying to take them down. This high infection rate seems to be the newest message from the other guys.

I pulled my personal data with Nevro from the past 12 months. I’m in a heavy stim practice and work with a lot of spine surgeons.

64 trials, 60 went to perm
Avg pain score after implant 2.8
Avg time since implant of the cohort 4.9 months
Post implant responder rate 78% in total
Post implant responder rate at 3 months 73%
Responder rate at 9 months 87%
0 infections

Looked back at my total number of implants since starting practice, have done 122 with the overwhelming majority Nevro, had 1 infection, it was a St Jude implant and the guy came down with the flu 2 weeks after implant and ended up in the ICU. Infection showed up on hospital day 4 so I’m not totally willing to take the blame on that one.

 

[Orin]

I assume then the reason Nevro hasn't taken the lion's share of the market, even with their data, is primarily because it's not reproducing in the real world, or that perhaps the 1khz stim is good enough.

My preference is still to paresthesia map while leaving electrodes covering the high frequency sweet spots, and whipping it in there blindly to the sweet spots without any plans for what to do if HF10 fails is idiotic.

But I agree, their data are great. I wonder how they would be if someone else called the patient and collected it.

 

[Aether2000]

The data presented above about infection rates may indeed be valid, but does not negate the fact that 42% of the last hundred MAUDE data entries for NEVRO were infections. I did the study myself without support from any company.

 

[epidural man]

What study has shown that 10,000Hz is better than 5000Hz? or 1200Hz? or 3547Hz? Who has shown that Hz matters, and electric field strength doesn't?

 

[lobelsteve]

What study has shown that 10,000Hz is better than 5000Hz? or 1200Hz? or 3547Hz? Who has shown that Hz matters, and electric field strength doesn't?

https://www.clinicalpainadvisor.com...ulation-for-postsurgical-pain/article/752908/

 

[bedrock]

I’ve been out of stim for 9 months, please educate me.
For argument sake let’s forget current MRI capability for now, as Nevro should have MRI approval this year, retroactive to previous cases.

So outside of very focal neuropathy such CRPS focused in foot, or focal neuropathy after hernia surgery or testicular pain for which you should do DRG stim, why would you use another company besides Nevro?

I’m genuinely asking. Is there something I’m missing?

 

[lobelsteve]

I’ve been out of stim for 9 months, please educate me.
For argument sake let’s forget current MRI capability for now, as Nevro should have MRI approval this year, retroactive to previous cases.

So outside of very focal neuropathy such CRPS focused in foot, or focal neuropathy after hernia surgery or testicular pain for which you should do DRG stim, why would you use another company besides Nevro?

I’m genuinely asking. Is there something I’m missing?

Nope, just some rabble rousers on the internet. Though I am interested to hear more about methodology of the reporting and Algos's findings. Epidural man got his mind made up.

 

[PapaDosh]

For those using Nevro- have you found the need to use more than one lead for primarily axial PLLBP? I had a trial recently, and it was definitely challenging to get both leads to lie exactly midline.

 

[244913]

For those using Nevro- have you found the need to use more than one lead for primarily axial PLLBP? I had a trial recently, and it was definitely challenging to get both leads to lie exactly midline.

Their leads don't steer very well c/w MDT and Boston. I almost always use two leads. Program 1 requires coverage of that 9/10 sweet spot and one lead is OK but if it moves..also staggering two contacts over the disc space helps in my experience

Steve had a good tip- start two levels below just medial to pedicle with Tuohy and come more shallow. The leads seem to drive easier with that entry

 

[PapaDosh]

Their leads don't steer very well c/w MDT and Boston. I almost always use two leads. Program 1 requires coverage of that 9/10 sweet spot and one lead is OK but if it moves..also staggering two contacts over the disc space helps in my experience

Steve had a good tip- start two levels below just medial to pedicle with Tuohy and come more shallow. The leads seem to drive easier with that entry

Thanks for tip! I wish I had read it before the trial though! I don't think I have ever had to place the Tuohy at such a shallow angle (it ended up being 15 degrees with a curved tip).

 

[244913]

I’ve been out of stim for 9 months, please educate me.
For argument sake let’s forget current MRI capability for now, as Nevro should have MRI approval this year, retroactive to previous cases.

So outside of very focal neuropathy such CRPS focused in foot, or focal neuropathy after hernia surgery or testicular pain for which you should do DRG stim, why would you use another company besides Nevro?

I’m genuinely asking. Is there something I’m missing?

Per my rep Nevro is now full body MRI approved which applies retroactively

 

[bedrock]

Per my rep Nevro is now full body MRI approved which applies retroactively

Unless that happened last week, I’m not so sure. I grilled the Nevro rep on this 10 days ago.

They do expect FDA approval this year for full body MRI which will be retroactive to previous implants.

 

[244913]

Unless that happened last week, I’m not so sure. I grilled the Nevro rep on this 10 days ago.

They do expect FDA approval this year for full body MRI which will be retroactive to previous implants.

Per my rep 3/22: "We are now FDA approved for MRI full body labeling for IPG 1500- this labeling is retroactive and applies to patients implanted with percutaneous leads. This approval includes conditional labeling for head and extremity MRI for out Surpass Surgical (paddle) lead."

 

[epidural man]

https://www.clinicalpainadvisor.com...ulation-for-postsurgical-pain/article/752908/

This is a synopsis of THIS article - and by my read, it actually argues in favor of the Ninja system.

https://onlinelibrary.wiley.com/doi/abs/10.1111/ner.12755

 

[epidural man]

I’ve been out of stim for 9 months, please educate me.
For argument sake let’s forget current MRI capability for now, as Nevro should have MRI approval this year, retroactive to previous cases.

So outside of very focal neuropathy such CRPS focused in foot, or focal neuropathy after hernia surgery or testicular pain for which you should do DRG stim, why would you use another company besides Nevro?

I’m genuinely asking. Is there something I’m missing?

I'm not sure DRG stim does better then Nevro for some of those. We have used Nevro for groin pain and got really great results - and it seems way easier than DRG stim placement.

Here is why I would perhaps use something other than Nevro.

No one has shown that frequency of stimulation matters. What people have attempted to show was that subthreshold stimulation seems to have advantages. However, no one really knows if that is an electric field strength phenomenon, or frequency phenomenon, or what it is. Secondly, people HAVE shown, that some people that don't respond to high frequency, WILL respond to threshold stimulation. Other people have shown that people also like the choice.

So I would say, why implant with a system that only offers one thing? And if that thing doesn't work, you are stuck.

Finally,
I will say...i'm not all that impressed with MRI compatibility. We only have 3T at our hospital anyway.

 

[lobelsteve]

I'm not sure DRG stim does better then Nevro for some of those. We have used Nevro for groin pain and got really great results - and it seems way easier than DRG stim placement.

Here is why I would perhaps use something other than Nevro.

No one has shown that frequency of stimulation matters. What people have attempted to show was that subthreshold stimulation seems to have advantages. However, no one really knows if that is an electric field strength phenomenon, or frequency phenomenon, or what it is. Secondly, people HAVE shown, that some people that don't respond to high frequency, WILL respond to threshold stimulation. Other people have shown that people also like the choice.

So I would say, why implant with a system that only offers one thing? And if that thing doesn't work, you are stuck.

Finally,
I will say...i'm not all that impressed with MRI compatibility. We only have 3T at our hospital anyway.

Your review of the literature differs than the fda's review who gave the nevro system superiority status over the Boston Scientific system at the time. MRI compatibility is a useless point because very few centers care. The radiologist doesn't want to bother calling me 800 number on the card and figuring out if their system is useful for getting an MRI on a patient with a stimulator. They will just send them somewhere else.

 

[244913]

I'm not sure DRG stim does better then Nevro for some of those. We have used Nevro for groin pain and got really great results - and it seems way easier than DRG stim placement.

Here is why I would perhaps use something other than Nevro.

No one has shown that frequency of stimulation matters. What people have attempted to show was that subthreshold stimulation seems to have advantages. However, no one really knows if that is an electric field strength phenomenon, or frequency phenomenon, or what it is. Secondly, people HAVE shown, that some people that don't respond to high frequency, WILL respond to threshold stimulation. Other people have shown that people also like the choice.

So I would say, why implant with a system that only offers one thing? And if that thing doesn't work, you are stuck.

Finally,
I will say...i'm not all that impressed with MRI compatibility. We only have 3T at our hospital anyway.

Nevro can do tonic- they don't like to, but they have the capability

 

[bedrock]

I'm not sure DRG stim does better then Nevro for some of those. We have used Nevro for groin pain and got really great results - and it seems way easier than DRG stim placement.

Here is why I would perhaps use something other than Nevro.

No one has shown that frequency of stimulation matters. What people have attempted to show was that subthreshold stimulation seems to have advantages. However, no one really knows if that is an electric field strength phenomenon, or frequency phenomenon, or what it is. Secondly, people HAVE shown, that some people that don't respond to high frequency, WILL respond to threshold stimulation. Other people have shown that people also like the choice.

So I would say, why implant with a system that only offers one thing? And if that thing doesn't work, you are stuck.

Finally,
I will say...i'm not all that impressed with MRI compatibility. We only have 3T at our hospital anyway.

That is a reasonable point. Met with the St Jude reps a couple weeks ago a and they mentioned that study and I can see it being nice to give the patients a choice of stim patterns. Make sense for primary limb pain with some axial, but for the more common patient with mostly axial pain with some limb pain, do you think that St Jude, etc works as well as Nevro for the axial pain?

Axial pain is still the holy grail.

 

[bedrock]

Nevro can do tonic- they don't like to, but they have the capability

Ah. I didn’t know that.

 

[244913]

That is a reasonable point. Met with the St Jude reps a couple weeks ago a and they mentioned that study and I can see it being nice to give the patients a choice of stim patterns. Make sense for primary limb pain with some axial, but for the more common patient with mostly axial pain with some limb pain, do you think that St Jude, etc works as well as Nevro for the axial pain?

Axial pain is still the holy grail.

I still think for level 1 evidence, Nevro is it for axial pain. I really like burstDR for primarily limb pain because the vast majority of my patients don't want paresthesias AND it has the option of a primary cell. I don't really buy the medial pathways "frontal lobotomy" stuff. Although Nevro also covers limb really well too. I've been pleasantly surprised.

To me, medtronic and Boston are dinosaurs. Why would I go with "high density" stim for axial when SENZA and FDA say Nevro is better and they are now MRI compatible AND they can do tonic (if you really push it)? Run high density on the medtronic or Boston battery at 1000 Hz and they are going to be recharging a lot- that is not what the battery was made for.

And why would I go with "cluster tonic" when I have the option of true "burst" with a battery that supports it?

I'll be hard pressed moving forward to ever use Boston or MDT again. Plus, in my area the Nevro and Abbot reps are fantastic, personable, not pushy, and really take care of my patients well AFTER I implant them. I will get texts from the Nevro rep 6 months after an implant that has been in the back of my mind, and he's giving me updates on how they are doing etc.

Finally, as an implanter, I do not like the Entrada needles- should be called "intradural" needles. These are required if you are going to use Infinions- unless you do splitters- which the Boston reps seem to insist is the only real way they can do HD or cluster tonic or the rest of this ninja BS.

BTW- I have no financial connection to any company. This is just personal preference and experience. I don't do dinners, I don't do jack with these people. If I meet them at Starbucks to discuss something I buy my own java

- ex 61N

 

[Orin]

So outside of very focal neuropathy such CRPS focused in foot, or focal neuropathy after hernia surgery or testicular pain for which you should do DRG stim, why would you use another company besides Nevro?

Well, you could also do a peripheral stimulator to avoid instrumenting the neuraxis for the focal neuralgias.

Nevro can do tonic- they don't like to, but they have the capability

Just because the equipment can do it, doesn't mean leads thrown in to the hotspots without any mapping can do tonic well. It's interesting having them turn on tonic to see where paresthesias are felt though.

In my hands, I haven't had luck with Nevro, but maybe I enrich for their failures with my meds or patient population. They all trial well, but they aren't as happy when I see them after the implants.

 

[epidural man]

Your review of the literature differs than the fda's review who gave the nevro system superiority status over the Boston Scientific system at the time. .

I don't think we are saying the same thing.

Nevro high frequency 10000Hz vs Boston tonic stim - FDA said Nevro is better? Does the FDA make statements about what company wins? Can you point me in the right direction?

What I am asking - is...has anyone shown that 10000Hz at X amplitude is better than 9000Hz at y Amplitude? Vs 5000Hz at Z amplitude? VS 1000Hz at a different wave form? (All subthreshold)

 

[244913]

Well, you could also do a peripheral stimulator to avoid instrumenting the neuraxis for the focal neuralgias.


Just because the equipment can do it, doesn't mean leads thrown in to the hotspots without any mapping can do tonic well. It's interesting having them turn on tonic to see where paresthesias are felt though.

In my hands, I haven't had luck with Nevro, but maybe I enrich for their failures with my meds or patient population. They all trial well, but they aren't as happy when I see them after the implants.

What do you think accounts for the difference between trial and post implant? This is a phenomenon I have observed with all systems but your comment is thought provoking..

This is something we have all seen occasionally and it is very frustrating

Placebo effect?

 

[Orin]

Is the Level 1 power of placebo better than the stuff we had before?

I think it's probably a function of my patient population/selection. I am realizing that some of them are just over stimming at HF10, so some do fine after a stim holiday. These are the folks that like the tingling feeling and knowing something is working.

I do tend to have a ton of non-opioid medications on board and I wonder if some of them interfere with the way HF10 works.

 

[Ducttape]

I read the article, and it appears to be a attempt to say that the Ninja system works better... than conventional but not HF stim.


in this study, HF was used as the shuffle when patient was in a particular position, otherwise it was conventional stim. ultimately, testing if, specifically, HF stim while recumbent was better.

this says nothing about the comparative difference between HF stim and shuffle stim. and as a correlary, maybe it is the HF that leads to pain reduction...

and interestingly, 2 (out of 13 people, or almost 15%) found no difference at all so were excluded from data analysis. that is a pretty big number.

 

[Orin]

and interestingly, 2 (out of 13 people, or almost 15%) found no difference at all so were excluded from data analysis. that is a pretty big number.

https://static.seekingalpha.com/uploads/2017/1/30/440063-14858251805920367_origin.png

The HF10 nonresponder rate is 12 - 24%.
- Why limit patients to HF10 with poorly mapped tonic?
- Why just do tonic without covering the cord where it responds to higher frequency ranges?

We need a new study comparing tonic, Burst, 1 khz, 10khz but no one is willing to risk it or has a platform which allows it. Then you've also got the problem with blinding the patient to tonic stimulation, lead placement for conventional vs high frequency, wash out, etc.

I think Stimwave's system might be the only one capable of doing something similar to all those frequencies, but I'm not sure they can fund that type of study.

I'm just happy to have options though I'm still not sure which one works best for the patient infront of me. I don't think it's a single solution.

 

[Ducttape]

If a patient is a non responder, don’t implant. Trials are predictive. Doing an implant then trying to change programs is desperation and destined to fail. Implanting and then hoping tonic will work is also ridiculous. Otherwise why not mandate that every American gets a stim placed with every spine surgery or any dx of neuropathic pain, just in case?

Not everyone gets better with
Stim.

This step by BS sounds just like their stance that the 32 contact leads would change everything about stim. Revolutionize it. You have total control.

 

[Orin]

If a patient is a non responder, don’t implant. Trials are predictive. Doing an implant then trying to change programs is desperation and destined to fail.

Those data are from implanted patients that passed their trials. That's the problem.

 

[Ducttape]

fyi, is your slide from the original article that lobelsteve posted?


because a slide in isolation of the "study" is hard to interpret.

btw, your datapoint on Sunburst suggests it is no different from the other tonic therapies.


and if not working, explant. I know of no data that suggests that a SCS that was previously ineffective suddenly became beneficial after being dormant.

 

[gdub25]

I assume then the reason Nevro hasn't taken the lion's share of the market, even with their data, is primarily because it's not reproducing in the real world, or that perhaps the 1khz stim is good enough.

My preference is still to paresthesia map while leaving electrodes covering the high frequency sweet spots, and whipping it in there blindly to the sweet spots without any plans for what to do if HF10 fails is idiotic.

But I agree, their data are great. I wonder how they would be if someone else called the patient and collected it.

I’m not sure what you mean about Nevro not reproducing the results in the real world. The data I listed above from my practice is real world And isn’t too far off from the study.

https://static.seekingalpha.com/uploads/2017/1/30/440063-14858251805920367_origin.png

The HF10 nonresponder rate is 12 - 24%.
- Why limit patients to HF10 with poorly mapped tonic?
- Why just do tonic without covering the cord where it responds to higher frequency ranges?

We need a new study comparing tonic, Burst, 1 khz, 10khz but no one is willing to risk it or has a platform which allows it. Then you've also got the problem with blinding the patient to tonic stimulation, lead placement for conventional vs high frequency, wash out, etc.

I think Stimwave's system might be the only one capable of doing something similar to all those frequencies, but I'm not sure they can fund that type of study.

I'm just happy to have options though I'm still not sure which one works best for the patient infront of me. I don't think it's a single solution.

You mention responder rate dropping by 12 to 24% after implant like that’s a bad thing. In every level one study ever done with tonic stimulation that number is more like 50%. I’m not saying high frequency is the best for every patient because there have been failed HF10 trials that have responded well to other stimulation in my practice but if I had to pick one to hang my hat on Nevro is the clear choice in my opinion.

 

[bedrock]

I’m not sure what you mean about Nevro not reproducing the results in the real world. The data I listed above from my practice is real world And isn’t too far off from the study.




You mention responder rate dropping by 12 to 24% after implant like that’s a bad thing. In every level one study ever done with tonic stimulation that number is more like 50%. I’m not saying high frequency is the best for every patient because there have been failed HF10 trials that have responded well to other stimulation in my practice but if I had to pick one to hang my hat on Nevro is the clear choice in my opinion.

Good points.

I think there is an argument to be made for considering abbott if the patient has mainly limb pain with a small amount of axial so you can switch between different types of stim, but I can't see why you would use anything but nevro for a patient with 50% of more of their pain being axial, and minority in the limb.

Anyone disagree with that statement?

 

[painfree23]

Good points.

I think there is an argument to be made for considering abbott if the patient has mainly limb pain with a small amount of axial so you can switch between different types of stim, but I can't see why you would use anything but nevro for a patient with 50% of more of their pain being axial, and minority in the limb.

Anyone disagree with that statement?

How do u get that approved??? Had one insurer decline my stim prior auth bc axial > radicular pain , even went to peer to peer.

 

[bedrock]

I can answer that, but only in the physicians forum.

 

[Timeoutofmind]

I’m not sure what you mean about Nevro not reproducing the results in the real world. The data I listed above from my practice is real world And isn’t too far off from the study.




You mention responder rate dropping by 12 to 24% after implant like that’s a bad thing. In every level one study ever done with tonic stimulation that number is more like 50%. I’m not saying high frequency is the best for every patient because there have been failed HF10 trials that have responded well to other stimulation in my practice but if I had to pick one to hang my hat on Nevro is the clear choice in my opinion.

Are you guys routinely re trialing with another company if they fail the first trial?

 

[lobelsteve]

Are you guys routinely re trialing with another company if they fail the first trial?

No. Bad form. Would always appear more for doc than patient.

 

[BobBarker]

Yes. I retrial if the patient is game for it.

 

[244913]

Are you guys routinely re trialing with another company if they fail the first trial?

I had a lady come to me who failed a medtronic trial somewhere else in the community. Primarily axial pain, they flailed away with tonic stim for 3 days after difficult lead placements under local and all she felt was tingling in her legs. I re-trialed with Nevro and she got 85% relief and scheduled for implant.

 

[gdub25]

Are you guys routinely re trialing with another company if they fail the first trial?

No, if after five days they are not doing well with Nevro we will bring them in for lead x-ray, if leads have not migrated then I will have another company hook up to the leads. Usually St. Jude with their Burst and then lastly move to tonic. I have a handful of patients who have gotten very little relief with Nevro and done better with Burst. Have also had it the other way around. If a patient underwent a trial with tonic stimulation somewhere else I do not hesitate to offer them a trial with Nevro if they come to see me for another opinion afterwards. The literature supports this in my opinion.

Good points.

I think there is an argument to be made for considering abbott if the patient has mainly limb pain with a small amount of axial so you can switch between different types of stim, but I can't see why you would use anything but nevro for a patient with 50% of more of their pain being axial, and minority in the limb.

Anyone disagree with that statement?

Can you explain your argument for Abbot with limb pain? Are you talking about DRG possibly? In the burst study their responder rate wasn’t very good at all with back or leg pain and in fact it underperformed the Medtronic tonic stim from the two studies done a decade prior as well as the Boston data in the tonic arm of the SENZA study.

With all of that said Saint Jude is the second company I go to after Nevro.

 

[Timeoutofmind]

No, if after five days they are not doing well with Nevro we will bring them in for lead x-ray, if leads have not migrated then I will have another company hook up to the leads. Usually St. Jude with their Burst and then lastly move to tonic. I have a handful of patients who have gotten very little relief with Nevro and done better with Burst. Have also had it the other way around. If a patient underwent a trial with tonic stimulation somewhere else I do not hesitate to offer them a trial with Nevro if they come to see me for another opinion afterwards. The literature supports this in my opinion.




Can you explain your argument for Abbot with limb pain? Are you talking about DRG possibly? In the burst study their responder rate wasn’t very good at all with back or leg pain and in fact it underperformed the Medtronic tonic stim from the two studies done a decade prior as well as the Boston data in the tonic arm of the SENZA study.

With all of that said Saint Jude is the second company I go to after Nevro.

Wow, very thoughtful
I like it

A couple of clarifications please
1. If you get an xray and the lead has migrated then what? Re-do the trial with new leads?

2. And also do you bother to get the xray even if they report coverage of their painful areas when the amplitude is turned up?

3. If the leads have not migrated, and you switch companies...how many days is this second part of the trial? Or if you go to a third company how many days for that? Dont you worry about infection leaving them in so long?

4. Are the reps from Abbott OK with this salvage type role? Seems like it would piss them off a bit...

 

[ziggyziggy]

So outside of very focal neuropathy such CRPS focused in foot, or focal neuropathy after hernia surgery or testicular pain for which you should do DRG stim, why would you use another company besides Nevro?

I’m genuinely asking. Is there something I’m missing?

I have 2 patients for groin pain after hernia repair who have done well with Nevro for about a year now. One patient is not on any narcotics anymore and Other get PRN Norco from PCP.

I do agree that Nevro leads don't steer well in comparison to others.

Yes. I retrial if the patient is game for it.

How long do you wait for retrial? Whats ur rationale for retrialing?

No, if after five days they are not doing well with Nevro we will bring them in for lead x-ray, if leads have not migrated then I will have another company hook up to the leads. Usually St. Jude with their Burst and then lastly move to tonic. I have a handful of patients who have gotten very little relief with Nevro and done better with Burst. Have also had it the other way around. If a patient underwent a trial with tonic stimulation somewhere else I do not hesitate to offer them a trial with Nevro if they come to see me for another opinion afterwards. The literature supports this in my opinion.

.

How long do you run burst before switching to tonic?

How do you get around insurance for switching IPG in between trial period?

 

[Orin]

So when I've had my Nevro folks turn on tonic with leads in the usual placement, they're not really able to capture anything of use, but that might be just them trying to not use tonic. I think early on they were heavily incentivized to not, but they're being pushed to do that once their algorithm is exhausted.

That led me to place another system's leads with tonic first, with care to place some electrodes over T9/10 or C2/C3 depending, because then I can start with a higher frequency stim if needed, but I've got tonic mapped to help define the cord I'm lighting up.

Generally the other reps eat the cost on the external unit/OMG/whatever the converter is, as capturing an implant is where their revenue is.

 

[BobBarker]

Both patients I retrialed failed St Jude burst trials. They then had successful Nuvectra trials. I rexamined them carefully and couldn’t find a reason that SCS shouldn’t have worked so I offered a trial with a different company. I have retrialed people
who have failed MDT trials years ago as well.

 

[studentologist]

I am pro Nevro as well. During fellowship we used mostly Nevro and Abbott/St Jude. I’ve had good results with Abbott/St Jude, but the Abbott/St Jude’s SUNBURST study has made me question if I should change my practice.

What do you all think about Boston Scientific’s LUMINA study and does anyone prefer Boston Scientific?

Looking at the Boston Scientific LUMINA study, the newer ‘Anatomically guided 3D neural targeting’ system seemed to show similar responder rates as Nevro and sustained relief at 24 months, like Nevro.

The LUMINA study and Nevro studies defined responders as >50% pain relief. (Abbott/St Jude’s SUNBURST study defined responders at >30% relief).

Boston Scientific had 213 patients in the 3D neural targeting SCS cohort. (For reference, Nevro has 101 patients randomized to HF10 therapy).

Using Boston Scientific’s 3D neural targeting, 74% of patients maintained >50% relief at 24 months. Mean overall pain scores went from 7.17 to 2.94 at 24 months. Low back pain went from 7.21 to 3.09 at 24 months.

Nevro had 76.5% for low back pain responders (>50% relief) and 72.9% for leg pain responders at 24 months. Back pain scores went from 7.4 to 2.4 and leg pain 7.1 to 2.4.

Thus, Boston Scientific’s 3D neural targeting system seems to have similar responder rates at 2 years compared to Nevro, but Nevro reached lower pain scores.

Regarding opioids, Nevro showed a statistically significant decrease. The LUMINA study didn’t really comment on opioids. SUNBURST reported increased “medication usage” in both the burst stimulation and tonic stimulation.

I haven’t heard anyone talk about the LUMINA study and it seems good to me. I’m trying to decide if I should start using more Boston Scientific.