2020 NANS Rumors, Gossip, and Innuendo...Post it all here...

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the usual critiques.
retrospective.
small sample size.
poor final assessment - using numeric pain scale.

in addition - different endpoints for determining final result.
confusing wording with regards to opioid use - "only 4 patients were using opioids, with the remainder of patients tapering of medication or reporting no opioid therapy".
er... doesn't "tapering of medication" mean patients are still using?

fwiw, slightly change the wording, and one could construe this study to show that people fail SCS for neurogenic claudication and should have had vertiflex put in instead.....

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the usual critiques.
retrospective.
small sample size.
poor final assessment - using numeric pain scale.

in addition - different endpoints for determining final result.
confusing wording with regards to opioid use - "only 4 patients were using opioids, with the remainder of patients tapering of medication or reporting no opioid therapy".
er... doesn't "tapering of medication" mean patients are still using?

fwiw, slightly change the wording, and one could construe this study to show that people fail SCS for neurogenic claudication and should have had vertiflex put in instead.....

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1580219494088.png
 
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Electric stem cells.


That is, pathological pain is being created and maintained by a surprising cell type, namely glia. These cells, upon activation, dysregulate normal pain processing by the spinal cord neurons. The aim of this research is to both understand how glia dysregulate neuronal function and, ultimately, to develop clinically relevant means to control such pain states.

Sci Rep. 2016 Aug 24;6:32096. doi: 10.1038/srep32096.
Mesenchymal Stem Cells Reversed Morphine Tolerance and Opioid-induced Hyperalgesia.
Hua Z1,2, Liu L1, Shen J1, Cheng K1, Liu A1, Yang J1, Wang L1, Qu T3, Yang H3, Li Y3, Wu H1, Narouze J1, Yin Y1, Cheng J1.
Author information

Abstract

More than 240 million opioid prescriptions are dispensed annually to treat pain in the US. The use of opioids is commonly associated with opioid tolerance (OT) and opioid-induced hyperalgesia (OIH), which limit efficacy and compromise safety. The dearth of effective way to prevent or treat OT and OIH is a major medical challenge. We hypothesized that mesenchymal stem cells (MSCs) attenuate OT and OIH in rats and mice based on the understanding that MSCs possess remarkable anti-inflammatory properties and that both OT and chronic pain are associated with neuroinflammation in the spinal cord. We found that the development of OT and OIH was effectively prevented by either intravenous or intrathecal MSC transplantation (MSC-TP), which was performed before morphine treatment. Remarkably, established OT and OIH were significantly reversed by either intravenous or intrathecal MSCs when cells were transplanted after repeated morphine injections. The animals did not show any abnormality in vital organs or functions. Immunohistochemistry revealed that the treatments significantly reduced activation level of microglia and astrocytes in the spinal cord. We have thus demonstrated that MSC-TP promises to be a potentially safe and effective way to prevent and reverse two of the major problems of opioid therapy.
PMID: 27554341 PMCID: PMC4995471 DOI: 10.1038/srep32096
[Indexed for MEDLINE] Free PMC Article

Clin Pharmacol Ther. 2018 Jun;103(6):971-974. doi: 10.1002/cpt.959. Epub 2017 Dec 29.
The Use of Stem Cell Therapy to Reverse Opioid Tolerance.
Li F1,2, Liu L2, Cheng K2, Chen Z1, Cheng J2.
Author information

Abstract

Opioid tolerance (OT) and opioid-induced hyperalgesia (OIH) are major challenges in medicine. Here we report that transplantation of mesenchymal stem cells (MSCs) prevented and reversed OT and OIH in rats and mice. The preventive and therapeutic effects were long-lasting and consistent across different assessment schemes. Both intrathecal and intravenous transplantations were effective and safe. This emerging therapeutic strategy has thus shown promise to impact clinical practice and improve the efficacy and safety of opioid therapy.
© 2018 American Society for Clinical Pharmacology and Therapeutics.
PMID: 29285750 DOI: 10.1002/cpt.959
[Indexed for MEDLINE]
 
same data, 2 different articles.

wow, that's innovative.

fwiw, rat and mice model, has to translate to human model. in addition, why no follow up data yet? that first study was done in 2016...


would be nice and risky in addiction medicine - if one reversed opioid tolerance, would that lead to greater accidental overdose? I am not interpreting these articles to suggest that there is significant change in the psychosocial aspects of addiction.
 

That is, pathological pain is being created and maintained by a surprising cell type, namely glia. These cells, upon activation, dysregulate normal pain processing by the spinal cord neurons. The aim of this research is to both understand how glia dysregulate neuronal function and, ultimately, to develop clinically relevant means to control such pain states.

Sci Rep. 2016 Aug 24;6:32096. doi: 10.1038/srep32096.
Mesenchymal Stem Cells Reversed Morphine Tolerance and Opioid-induced Hyperalgesia.
Hua Z1,2, Liu L1, Shen J1, Cheng K1, Liu A1, Yang J1, Wang L1, Qu T3, Yang H3, Li Y3, Wu H1, Narouze J1, Yin Y1, Cheng J1.
Author information

Abstract

More than 240 million opioid prescriptions are dispensed annually to treat pain in the US. The use of opioids is commonly associated with opioid tolerance (OT) and opioid-induced hyperalgesia (OIH), which limit efficacy and compromise safety. The dearth of effective way to prevent or treat OT and OIH is a major medical challenge. We hypothesized that mesenchymal stem cells (MSCs) attenuate OT and OIH in rats and mice based on the understanding that MSCs possess remarkable anti-inflammatory properties and that both OT and chronic pain are associated with neuroinflammation in the spinal cord. We found that the development of OT and OIH was effectively prevented by either intravenous or intrathecal MSC transplantation (MSC-TP), which was performed before morphine treatment. Remarkably, established OT and OIH were significantly reversed by either intravenous or intrathecal MSCs when cells were transplanted after repeated morphine injections. The animals did not show any abnormality in vital organs or functions. Immunohistochemistry revealed that the treatments significantly reduced activation level of microglia and astrocytes in the spinal cord. We have thus demonstrated that MSC-TP promises to be a potentially safe and effective way to prevent and reverse two of the major problems of opioid therapy.
PMID: 27554341 PMCID: PMC4995471 DOI: 10.1038/srep32096
[Indexed for MEDLINE] Free PMC Article

Clin Pharmacol Ther. 2018 Jun;103(6):971-974. doi: 10.1002/cpt.959. Epub 2017 Dec 29.
The Use of Stem Cell Therapy to Reverse Opioid Tolerance.
Li F1,2, Liu L2, Cheng K2, Chen Z1, Cheng J2.
Author information

Abstract

Opioid tolerance (OT) and opioid-induced hyperalgesia (OIH) are major challenges in medicine. Here we report that transplantation of mesenchymal stem cells (MSCs) prevented and reversed OT and OIH in rats and mice. The preventive and therapeutic effects were long-lasting and consistent across different assessment schemes. Both intrathecal and intravenous transplantations were effective and safe. This emerging therapeutic strategy has thus shown promise to impact clinical practice and improve the efficacy and safety of opioid therapy.
© 2018 American Society for Clinical Pharmacology and Therapeutics.
PMID: 29285750 DOI: 10.1002/cpt.959
[Indexed for MEDLINE]
No. Just no.
 
Injecting stem cells into the spine to treat a condition that is treated by just stopping the offending drug? And apparently as a justification of continuing or starting opioids by blocking tolerance and OIH?

What happens to a person if you block their OIH and continue prescribing opioids? Will they be happy or pissed at you? And, does buprenorphine block OIH via kappa antagonism and OPL-1 agonism? And, if it does, is it equitable to favor one method of blocking OIH over another?
 



Anyone hear about the Q&A after this poster was presented? I wasn’t there but did hear some others talking about it and apparently the presenter was challenged by some in the audience and it was a little awkward: quotes like “as the guy on the podium isn’t it your responsibility to know where this data is coming from” and the presenter eventually stating something along the lines of “well, maybe we should have left that data out”.
Given the title of this thread, figured I’d throw out the first real gossip
 
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Anyone hear about the Q&A after this poster was presented? I wasn’t there but did hear some others talking about it and apparently the presenter was challenged by some in the audience and it was a little awkward: quotes like “as the guy on the podium isn’t it your responsibility to know where this data is coming from” and the presenter eventually stating something along the lines of “well, maybe we should have left that data out”.
Given the title of this thread, figured I’d throw out the first real gossip
1580360812518.png
 
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Someone is going to get "wacked" by the Pain Mafia for presenting data that negatively impacts La Famiglia
 
your explant rate article is kind of GIGO.

how does the explant rate compare with "low" frequency SCS? suppose I tell you that those practices have an explant rate across the board of 75%? what does that do to your data?

if they have 3 year follow up, considering Senza-RCT study was posted in Anesthesiology in Oct 2015, they must have been very early adaptors of the technology. makes me wonder if their prescreening has changed since they started brand new technology. mine has.



but its pleasing to put such info in a poster - you get to present!
 
your explant rate article is kind of GIGO.

how does the explant rate compare with "low" frequency SCS? suppose I tell you that those practices have an explant rate across the board of 75%? what does that do to your data?

if they have 3 year follow up, considering Senza-RCT study was posted in Anesthesiology in Oct 2015, they must have been very early adaptors of the technology. makes me wonder if their prescreening has changed since they started brand new technology. mine has.



but its pleasing to put such info in a poster - you get to present!
1580409483909.png
 
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how does the explant rate compare with "low" frequency SCS? suppose I tell you that those practices have an explant rate across the board of 75%? what does that do to your data?

Agree, but the 2nd poster shows with multivariate analysis that older age (Hazard ratio of ~1.025) and use of HF10 (HR of ~4.279 with wide CI) were predictors for explant as compared to tonic or Burst usage.
 
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Electric stem cells.

Boom...

Neuromodulation. 2020 Feb 6. doi: 10.1111/ner.13105. [Epub ahead of print]
Pulsed Radiofrequency Neuromodulation Contributes to Activation of Platelet-Rich Plasma in In Vitro Conditions.
Michno A1, Kirkor Z2, Gojtowska E1, Suchorzewski M3, Śmietańska I3, Baścik B4.
Author information

Abstract

OBJECTIVES:
Recent years have brought new developments in interventional chronic pain management, namely regenerative orthopedics utilizing platelet-rich plasma (PRP) as well as further evolution of pulsed radiofrequency neuromodulation (PRF). Both methods have been used separately. Here, we investigated whether PRF may potentiate the activation of platelets in PRP samples when both these techniques are combined together in in vitro conditions.
MATERIALS AND METHODS:
Studies were performed on concentrated PRP samples (PRPs) obtained from acid citrate dextrose-treated blood taken from 11 healthy volunteers. PRPs were divided into four groups: 1) nonactivated PRP; 2) thrombin-activated PRP as a positive control for maximal platelets activation; 3) PRF-treated PRP exposed for 20 min to PRF energy generated by neurotherm radio frequency generator at 500 kHz, with a voltage of 40 V and maximal temperature of 42°C; and 4) a combination of groups 2 and 3.
RESULTS:
PRF-induced platelet activation measured by platelet factor 4 (PF4) and ATP release from PRPs was significantly higher compared to nonactivated PRPs, and similar to PF4 and ATP release from thrombin-activated PRPs. Thrombin activation did not potentiate PF4 release in PRF samples and even reduced ATP level. Additionally, PRF neither induced any platelet membrane damage measured by lactic dehydrogenase release from PRP nor modified any platelets viability or metabolism measured by MTT.
CONCLUSIONS:
We confirmed that PRF may activate PRP without additional platelet activators. So, a combination of both methods PRF and PRP application may provide a more effective opportunity for tissue regeneration in dentistry, surgery, dermatology, or in orthopedics.
© 2020 International Neuromodulation Society.
KEYWORDS:
Chronic pain; platelet activation; platelet-rich plasma; pulsed radiofrequency neuromodulation; regenerative treatment
PMID: 32027438 DOI: 10.1111/ner.13105
 
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This reflects my experience with stims implanted for back pain. I stopped counting the number of stims I have explanted (not implanted by me) for back pain.

It is the right tool, but the wrong anatomic placement.

not saying I disagree, the problem is there is a ‘high level’ study that says otherwise...
 
That explant study can't be discussed without first mentioning the fact that 65.9% of the pts had prior stimulators implanted before HF10 conversion.

Those pts weren't likely to respond to any SCS, and were already heading towards explant anyways.

Doesn't change the fact that a huge percentage of SCS units come out (across the board)...
 
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Doesn't change the fact that a huge percentage of SCS units come out (across the board)...

I have no reference for this fact. The references I've seen talk about a 5-10% explant rate at 5-years.
 
No one ever talked about explant rates until Nevro came around. It’s been the one thing that every other company keeps pointing at and holding on to. To me it wouldn’t matter if 30% of all SCS patients were explanted if that meant the other 70% were doing well. That’s great considering these patients had stimulators place because they were otherwise out of options. There is all of the sudden this focus on explant rate and I truly believe it’s white noise created by competing companies. No one is talking about the fact that traditional SCS and Burst have never had a responder rate greater than 50% in a level 1 study but rather they point out they don’t get explanted. The duration of implant doesn’t correlate with improvement in pain scores, ODI, reduction in opioids, etc so I’d love to see us all tune out the noise. An SCS system that is explanted is a huge waste of money and resources, yes, but an implanted system that doesn’t reduce opioid consumption, improve pain scores, or result in patients back to work or improved ODI is an equal waste of money and resources.
 
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No one ever talked about explant rates until Nevro came around. It’s been the one thing that every other company keeps pointing at and holding on to. To me it wouldn’t matter if 30% of all SCS patients were explanted if that meant the other 70% were doing well. That’s great considering these patients had stimulators place because they were otherwise out of options. There is all of the sudden this focus on explant rate and I truly believe it’s white noise created by competing companies. No one is talking about the fact that traditional SCS and Burst have never had a responder rate greater than 50% in a level 1 study but rather they point out they don’t get explanted. The duration of implant doesn’t correlate with improvement in pain scores, ODI, reduction in opioids, etc so I’d love to see us all tune out the noise. An SCS system that is explanted is a huge waste of money and resources, yes, but an implanted system that doesn’t reduce opioid consumption, improve pain scores, or result in patients back to work or improved ODI is an equal waste of money and resources.

Agreed. It isn't perfect, but nothing is...

The SCS patient population is already at the end of the line, and they've already failed everything else.
 
Agreed. It isn't perfect, but nothing is...

The SCS patient population is already at the end of the line, and they've already failed everything else.

How much sooner before the end of the line should we be making this therapy available to them? Nothing works at the end of the line...
 
How much sooner before the end of the line should we be making this therapy available to them? Nothing works at the end of the line...

That's a good Q, and I don't know the answer.

If it is FBSS I wait until the pt decides they want to try it, but rural Georgia pts think that electricity stuff "ain't right."

There are two spine surgeons in my group and I'm the only guy doing stim and I could do A LOT of stim and drive a much nicer car (Honda Accord).

I'm just not impressed with stim for FBSS, but I do think it is good for FBSS with persistent radiculitis. I can't deny that. I tend to wait and hold back more often than maybe I should.

It is BS to say Nevro is explanted more often than Abbott, Boston, MT...There's nothing specifically negative about Nevro that requires it to come out more than any other device. Abbott fails ALL THE GD TIME FOR ME...
 
That's a good Q, and I don't know the answer.

If it is FBSS I wait until the pt decides they want to try it, but rural Georgia pts think that electricity stuff "ain't right."

There are two spine surgeons in my group and I'm the only guy doing stim and I could do A LOT of stim and drive a much nicer car (Honda Accord).

I'm just not impressed with stim for FBSS, but I do think it is good for FBSS with persistent radiculitis. I can't deny that. I tend to wait and hold back more often than maybe I should.

It is BS to say Nevro is explanted more often than Abbott, Boston, MT...There's nothing specifically negative about Nevro that requires it to come out more than any other device. Abbott fails ALL THE GD TIME FOR ME...
I think you’re right - this may be the new angle of attack for BoSci - they were all about “options” but now Nevro is advertising the ability to do HF/low frequency/burst variant that’s not a differentiating factor for them.
 
not saying I disagree, the problem is there is a ‘high level’ study that says otherwise...

I understand. Look at the authors of those studies. It reads like a "who's who" of industry crooks. I like to sleep at night, so I have refused industry affiliation/consultant roles.

I think in 30 years of doing these (and using Nevro when they came out) that I can count the number of patients who had SIGNIFICANT relief of back pain with a stim on one hand.

Oddly, many of the patients I have personally explanted were the "successes" in the study. I guess a "success" depends on who is doing the data evaluation and how much they are getting paid.
 
It is BS to say Nevro is explanted more often than Abbott, Boston, MT...There's nothing specifically negative about Nevro that requires it to come out more than any other device. Abbott fails ALL THE GD TIME FOR ME...
So it's not BS as these are their data, but I suspect it's a manifestation of the nocebo response. Tonic paresthesia stimulation has a positive placebo effect that likely reinforces the device is working, while sub-paresthesia or paresthesia free systems don't get that benefit.
 
So it's not BS as these are their data, but I suspect it's a manifestation of the nocebo response. Tonic paresthesia stimulation has a positive placebo effect that likely reinforces the device is working, while sub-paresthesia or paresthesia free systems don't get that benefit.

Nevro is capable of all the same waveforms, and that poster up above included 65.9% of subjects had previous stimulators. So most were failures prior to Nevro being placed for salvage.

My point is there is nothing to my knowledge that is special about Nevro that requires explant.

I'm happy to learn what is specific to Nevro that doesn't exist in Abbott, MT, Boston that requires explant, because I really don't know. I'm not saying Nevro is perfect, and I use more Abbott than Nevro bc of the battery situation.

Edit - That poster above...Two of the authors see below...
 

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Wait... linq is also a casino accross the street from Caesar’s... is that maybe related to a NANs meeting/deal?


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And Omnia is the club in Caesars!


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Nevro is capable of all the same waveforms, and that poster up above included 65.9% of subjects had previous stimulators. So most were failures prior to Nevro being placed for salvage.

My point is there is nothing to my knowledge that is special about Nevro that requires explant.

I'm happy to learn what is specific to Nevro that doesn't exist in Abbott, MT, Boston that requires explant, because I really don't know. I'm not saying Nevro is perfect, and I use more Abbott than Nevro bc of the battery situation.

Edit - That poster above...Two of the authors see below...
You won the argument. Paid to play. Paid to publish data.
 
Nevro is capable of all the same waveforms, and that poster up above included 65.9% of subjects had previous stimulators. So most were failures prior to Nevro being placed for salvage.

My point is there is nothing to my knowledge that is special about Nevro that requires explant.

I'm happy to learn what is specific to Nevro that doesn't exist in Abbott, MT, Boston that requires explant, because I really don't know. I'm not saying Nevro is perfect, and I use more Abbott than Nevro bc of the battery situation.

Edit - That poster above...Two of the authors see below...

Nevro is now capable of all waveforms. Their early reps were not trained in tonic programming and a lot of the implanters in their rush to not test were getting sloppy with their "midline" placement leading to poor tonic/paresthesia capture. The lack of intraoperative mapping pushed some to adopt Nevro as it simplified the implant process and allowed for more cases per day for implanters without having to stress the wake-up/mapping. That was likely the hardware issue underlying many of the explants, I suspect.

Regardless, their battery was also the largest and I suspect patients also had more pocket pain issues, but I don't know.

With regards to the device/industry money, you can't cook the data that much on a retrospective analysis, but it may be that they were more okay with explanting a device they didn't believe in.

It's easier to accept failure when you're not washed in the blood.
 
Nevro is now capable of all waveforms. Their early reps were not trained in tonic programming and a lot of the implanters in their rush to not test were getting sloppy with their "midline" placement leading to poor tonic/paresthesia capture. The lack of intraoperative mapping pushed some to adopt Nevro as it simplified the implant process and allowed for more cases per day for implanters without having to stress the wake-up/mapping. That was likely the hardware issue underlying many of the explants, I suspect.

Regardless, their battery was also the largest and I suspect patients also had more pocket pain issues, but I don't know.

With regards to the device/industry money, you can't cook the data that much on a retrospective analysis, but it may be that they were more okay with explanting a device they didn't believe in.

It's easier to accept failure when you're not washed in the blood.

I'm sorry but in my experience there's no magic to electrode placement as long as it is midline and reasonably well placed. You do a trial and it migrates but still works, and you do an implant and it migrates but the pt tells you it's still working. I say this bc of the fact you don't map with Nevro obviously.

You definitely CAN walk your research in any direction you want it to go. That poster talks about HF10 failure and 2/3 of the pts were prior stim failures reimplanted with Nevro. That's being set up to fail IMO. Every device on the market would fail at a similar rate. How many people who read that poster actually read the poster and knew that vs the number of people who skimmed it and just saw a graph with a negative trend and a bunch of HF10 explants?

It's all BS. All of this is gamesmanship by rival stim companies. Abbott recently sent their dumba** rep to tell me about their new 10 yr battery...What a complete joke that is...It is the same battery but now it runs for like 30 sec and then doesn't run for 5 min...Something stupid like that.

I don't have as much experience as a lot of yall do but jeez man...The stim industry is total BS.
 
Stim companies play all the ignorant doctors. You’re right about the graph, most folks see that and the take away is HF10 must suck. They don’t read the whole design and understand most patients already failed traditional stim. They also never know the story behind the guys enrolling in the study and the fact that there were alleged confounding factors like romantic interests with reps from certain companies.
 
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I'm sorry but in my experience there's no magic to electrode placement as long as it is midline and reasonably well placed. You do a trial and it migrates but still works, and you do an implant and it migrates but the pt tells you it's still working. I say this bc of the fact you don't map with Nevro obviously.

You definitely CAN walk your research in any direction you want it to go. That poster talks about HF10 failure and 2/3 of the pts were prior stim failures reimplanted with Nevro. That's being set up to fail IMO. Every device on the market would fail at a similar rate. How many people who read that poster actually read the poster and knew that vs the number of people who skimmed it and just saw a graph with a negative trend and a bunch of HF10 explants?

It's all BS. All of this is gamesmanship by rival stim companies. Abbott recently sent their dumba** rep to tell me about their new 10 yr battery...What a complete joke that is...It is the same battery but now it runs for like 30 sec and then doesn't run for 5 min...Something stupid like that.

I don't have as much experience as a lot of yall do but jeez man...The stim industry is total BS.

Midline and reasonable is relative it seems. I see a good bit of poor placements, even with helter skelter paddles. With the paresthesia free systems, it does appear less sensitive to micro/macro-motion from a patient's perspective, but with paresthesia systems, those few millimeters can screw you if the reps don't know how to play with the parameters to get coverage.

The first poster is indicative of the problem you see. A lot of doctors went hard on the SENZA data and were replacing old batteries, but a good number of them came out. Nevro marketed their level 1 data aggressively, but the reality hasn't been that great in my hands for sure. The second poster is a little harder to argue with as those are primary implants. Their explant rate is also a bit higher than I have seen at 14% @ 2 years and 31% @ 5 years.

All of this is about market share for sure, but the question is does it make sense. If something was head and shoulders better, I would assume we would all agree and use it, but SCS/PNS is more than just delivering the right electricity with the right hardware unfortunately. FWIW, I hate prime cells as I lose flexibility in programming.
 
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Midline and reasonable is relative it seems. I see a good bit of poor placements, even with helter skelter paddles. With the paresthesia free systems, it does appear less sensitive to micro/macro-motion from a patient's perspective, but with paresthesia systems, those few millimeters can screw you if the reps don't know how to play with the parameters to get coverage.

The first poster is indicative of the problem you see. A lot of doctors went hard on the SENZA data and were replacing old batteries, but a good number of them came out. Nevro marketed their level 1 data aggressively, but the reality hasn't been that great in my hands for sure. The second poster is a little harder to argue with as those are primary implants. Their explant rate is also a bit higher than I have seen at 14% @ 2 years and 31% @ 5 years.

All of this is about market share for sure, but the question is does it make sense. If something was head and shoulders better, I would assume we would all agree and use it, but SCS/PNS is more than just delivering the right electricity with the right hardware unfortunately. FWIW, I hate prime cells as I lose flexibility in programming.
I think this comes down to patient selection. People who took the Senza data as carte blanche to implant anyone with axial only back pain regardless of the character of said pain are of course seeing higher explant rates.
 
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