Closed loop

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MitchLevi

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Saluda rep stopped by today. I haven't spoken to them yet.

I've been interested in this system for awhile now.

Anyone have experience with this, and if so what's up?

How big is the IPG (Eterna ruined me)?

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Saluda rep stopped by today. I haven't spoken to them yet.

I've been interested in this system for awhile now.

Anyone have experience with this, and if so what's up?

How big is the IPG (Eterna ruined me)?
Had coffee with rep last week. 12 contact leads. Ipg about same as Nevro. Unsure if measuring APs would provide long term differences in SCS outcomes.
 
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I was under the impression that private payers have updated their SCS guidelines to explicitly exclude closed loop stimulation

IMG_9859.jpeg
 
I was under the impression that private payers have updated their SCS guidelines to explicitly exclude closed loop stimulation

View attachment 380895
Super confusing image. Burst is investigational? PHN is investigational? I thought all payers were on board with nonsurgical low back pain?
 
Super confusing image. Burst is investigational? PHN is investigational? I thought all payers were on board with nonsurgical low back pain?

Stimulator companies will never tell you this. You have to read the guidelines yourself. This is from Evicore which is one of the big third party reviewers.
 
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I have done about 20 Saluda trials in the last 4 months. The takeaway so far is that our trial to implant ratio has gone down. We have had clear cut trial failures as opposed to the ones where patients “think they are better”. So I think from that perspective there will be less explants than other products. The ones that have gone to implant are good though. We are tracking the data as far as ODI etc and will hopefully get a clearer picture.

On the whole I’m not sure it’s that much better than the other products out there.
 
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I just looked at my numbers again. 50% implant rate so far on Saluda. So that’s a big drop off from Nevro/abbott numbers for my practice.

An interesting side note. I retrialed 3 of the failures with Nevro and they all failed those trials as well.
 
I just looked at my numbers again. 50% implant rate so far on Saluda. So that’s a big drop off from Nevro/abbott numbers for my practice.

An interesting side note. I retrialed 3 of the failures with Nevro and they all failed those trials as well.
interesting, you can retrial the patients? how much Saluda cost?
 
interesting, you can retrial the patients? how much Saluda cost?
oh god. no....

barring wildly unforeseen circumstances, please do not make it standard practice to order retrials. we do not need to be giving CMS more reason to get rid of neuromodulation as a treatment option.

please complete and finish the below statement:

the definition of stupidity is...
 
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oh god. no....

barring wildly unforeseen circumstances, please do not make it standard practice to order retrials. we do not need to be giving CMS more reason to get rid of neuromodulation as a treatment option.

please complete and finish the below statement:

the definition of stupidity is...
your above statement… you don’t know me or my patients or my practice, but to counter your statement. We have trialed two patients with failed devices that have been home run successful implants with Saluda
 
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In general patients can have two trials if needed per the Medicare guidelines

Cost wise Saluda is comparable to the other companies.
Thanks, appreciate the information, interesting to know that the closed loop can work for people who failed other types of stim.
 
your above statement… you don’t know me or my patients or my practice, but to counter your statement. We have trialed two patients with failed devices that have been home run successful implants with Saluda
um... whose message did i respond to?

it wasnt yours. i had no intention of implying that what you were doing was inappropriate, and if you took it that way, i apologize.

i guess i better be ultra specific.

i can see how, by misinterpreting some of these posts, someone could develop the concept of abusing the system by retrialing everyone ad infinitum -

It is Not Standard of Care to routinely retrial patients.

if someone decides to retrial a patient, they should document very clearly the reasons for the failure of the first trial and why a second trial is indicated
 
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um... whose message did i respond to?

it wasnt yours. i had no intention of implying that what you were doing was inappropriate, and if you took it that way, i apologize.

i guess i better be ultra specific.

i can see how, by misinterpreting some of these posts, someone could develop the concept of abusing the system by retrialing everyone ad infinitum -

It is Not Standard of Care to routinely retrial patients.

if someone decides to retrial a patient, they should document very clearly the reasons for the failure of the first trial and why a second trial is indicated
I thought you replied to my post by mistake, there was just a question of retrialing there, I do not retrial the patient in the same segment. lol
 
um... whose message did i respond to?

it wasnt yours. i had no intention of implying that what you were doing was inappropriate, and if you took it that way, i apologize.

i guess i better be ultra specific.

i can see how, by misinterpreting some of these posts, someone could develop the concept of abusing the system by retrialing everyone ad infinitum -

It is Not Standard of Care to routinely retrial patients.

if someone decides to retrial a patient, they should document very clearly the reasons for the failure of the first trial and why a second trial is indicated
I’m too sensitive lol
 
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If i recall correctly they have 3-5 year data with response rate in 70-80% as opposed to 50% for other companies.
which was interesting - it can mean you may be able to capture some patients who were initial responders who subsequently fail SCS
 
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Saluda has a passthrough for superiority for CMS for another 2 years I think?
 
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Saluda has a passthrough for superiority for CMS for another 2 years I think?
Orin could you please explain what pass through for superiority means? Thank you.
 
In general patients can have two trials if needed per the Medicare guidelines

Cost wise Saluda is comparable to the other companies.

Saluda is way more expensive compared to Medtronic/Abbott/Nevro/Boston. We’ve negotiated with them extensively and have mutually decided it’s not going to work. They were 4k more per implant.

Yes, they have a C code that allows for additional reimbursement but because of how the additional payment is calculated it only offsets the higher implant cost in hospitals with high price point to begin with. In our ASC, even with the additional C code we were losing money compared to every other company.

Orin could you please explain what pass through for superiority means? Thank you.

Because of their study CMS granted them a “superiority rating” and allows them to have access to a special C code that if billed will reimburse a little on top of the normal code. It’s meant to reward companies bringing new products to market after investing into research and product developement.
 
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Yes I’m HOPD based so we do everything in hospital coding. For us at least they brought down the prices to Abbott pricing and added a rebate of 2k per implant as well. That with the additional coding makes Saluda cheaper
 
Regarding retrials: I have done a few. Usually, a MDT or BSX failure then retrial with Nevro.
 
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Saluda is way more expensive compared to Medtronic/Abbott/Nevro/Boston. We’ve negotiated with them extensively and have mutually decided it’s not going to work. They were 4k more per implant.

Yes, they have a C code that allows for additional reimbursement but because of how the additional payment is calculated it only offsets the higher implant cost in hospitals with high price point to begin with. In our ASC, even with the additional C code we were losing money compared to every other company.



Because of their study CMS granted them a “superiority rating” and allows them to have access to a special C code that if billed will reimburse a little on top of the normal code. It’s meant to reward companies bringing new products to market after investing into research and product developement.
Great post as always.
 
Saluda is way more expensive compared to Medtronic/Abbott/Nevro/Boston. We’ve negotiated with them extensively and have mutually decided it’s not going to work. They were 4k more per implant.

Yes, they have a C code that allows for additional reimbursement but because of how the additional payment is calculated it only offsets the higher implant cost in hospitals with high price point to begin with. In our ASC, even with the additional C code we were losing money compared to every other company.



Because of their study CMS granted them a “superiority rating” and allows them to have access to a special C code that if billed will reimburse a little on top of the normal code. It’s meant to reward companies bringing new products to market after investing into research and product developement.
Right, to add on, this is identical to what Nevro had with HF10 after Senza. It's supposed drive physician behavior a bit to adopt the 'superior' therapy.
 
I believe the closed loop device was studied in a 3 year prospective fashion. Crossover study open loop vs closed loop, blinded. Called the Evoke study.

It will take a few days to get through.

I mean just the COI:

Conflict of interest statement​

Competing interests: NM reports personal fees from Saluda Medical for acting as independent medical monitor for the EVOKE study during the conduct of the study; he reports receiving grants from Neuros and Mesoblast, as well as consulting as a medical monitor for Nevro, Vivex, Mainstay, and Vertos outside the submitted work. RL is an uncompensated consultant for Nalu, Saluda Medical, and Mainstay Medical and has stock options from Nalu and Saluda Medical obtained before 2019, not exercisable through the duration of his term as International Neuromodulation Society President and editor-in-chief of the journal Neuromodulation: Technology at the Neural Interface. TD reports personal fees from Saluda Medical during the conduct of the study; consultancy for Axonics, Abbott, Nalu, Vertos, SpineThera, Mainstay, Cornerloc, Ethos, SPR Therapeutics, Medtronic, Boston Scientific, PainTeq, Tissue Tech, Spinal Simplicity, and Avanos outside the submitted work. He is a minor equity holder for Saluda Medical, Nalu, SpineThera, Stimgenics, Vertiflex, Vertos, and Bioness and an advisory board member for Abbott, Vertos, Nalu, SPR Therapeutics, and Tissue Tech. LK reports receiving grants from Nevro, Neuros, Avanos, Medtronic, Neuralace, and Xalud Therapeutics and financial support from Nevro, Avanos, and Saluda Medical outside the submitted work. SL reports receiving grants and personal fees from Saluda Medical during the conduct of the study; he reports grants from Avanos, Boston Scientific, Nalu Medical, SPR Therapeutics, Averitas Pharma, Biotronik, SGX Therapeutics, and PainTeq, as well as consultancy for Abbott, Avanos, Boston Scientific, Nevro, SPR Therapeutics, Averitas Pharma, Biotronik, Nalu Medical, and PainTeq, outside the submitted work, as well as holding stock options for Nalu Medical. KA reports consultancy for Medtronic, Nevro, Boston Scientific, Nalu, Presidio, Biotronik, Mesoblast, Vivex Laboratories outside the submitted work. JP reports research and consulting fees from Saluda Medical during the conduct of the study; consultancy for Abbott, Medtronic, Saluda Medical, Flowonix, SpineThera, Vertos, Vertiflex, SPR Therapeutics, Tersera, Aurora, Spark, Ethos, Biotronik, Mainstay, WISE, Boston Scientific, and Thermaquil outside the submitted work; has received grant and research support from: Abbott, Flowonix, Aurora, Painteq, Ethos, Muse, Boston Scientific, SPR Therapeutics, Mainstay, Vertos, AIS, and Thermaquil outside the submitted work; and is a shareholder of Vertos, SPR Therapeutics, Painteq, Aurora, Spark, Celeri Health, Neural Integrative Solutions, Pacific Research Institute, Thermaquil, and Anesthetic Gas Reclamation. CH reports grants from Saluda Medical during the conduct of the study; consultancy fees from Genecentrix outside the submitted work. SC reports grants from Cleveland Clinic during the conduct of the study; and grants from Vertos, Mainstay, and Vivex outside the submitted work. SMF reports consulting fees from Abbott, Medtronic, Saluda, VertiFlex, Vertos, Surgentec, CornerLoc, Mainstay and Relievant outside the submitted work, has received grant for research funding from Mainstay, Relievant, Medtronic, Abbott, VertiFlex, Saluda, Nalu, CornerLoc, Aurora, Biotronik, and Stimgenics outside the submitted work, and has an equity position in SynerFuse, Aurora Spine, Thermaquil. SPR Therapeutics, Saluda, CornerLoc, PainTEQ, Stimgenics, Anesthetic Gas Reclamation, Neural Integrative Solutions, SpineThera, and Celeri Health. CG reports clinical trial funding from Saluda Medical during the conduct of the study; reports personal fees and other from SPR, and personal fees from Nevro, Nalu, Biotronik, and Boston Scientific outside the submitted work. PSS has received consultancy fees from Medtronic, Saluda Medical, Nalu, and Biotronic outside the submitted work, and has stock options from Saluda Medical and Nalu. JS reports personal fees from Nevro during the conduct of the study and personal fees from Saluda Medical and Boston Scientific outside the submitted work. TM reports research fees from Saluda Medical during the conduct of the study and personal fees from Nevro outside the submitted work. JC reports personal fees from Saluda Medical during the conduct of the study; personal fees from Abbott, Boston Scientific, Nevro, Medtronic, Mainstay, SPR Therapeutics, CornerLoc, PillNurse, Biotronik, and Vivex outside the submitted work; and stock from Mainstay, CornerLoc, and PillNurse. EP has received research support from Mainstay, Medtronic, Neuros Medical, Nevro Corp, ReNeuron, SPR, and Saluda Medical outside the submitted work, as well as personal fees from Abbott Neuromodulation, Biotronik, Medtronic Neuromodulation, Nalu, Neuros Medical, Nevro, Presidio Medical, Saluda Medical, and Vertos outside the submitted work. She holds stock options from SynerFuse and neuro42. JMH reports consulting fees from Abbott, Boston Scientific, Nevro, and Saluda Medical outside the submitted work. RR reports grants from SPR, Nalu and Nevro outside the submitted work,l fees from Presidio, and grants and personal fees from Boston Scientific and Saluda Medical outside the submitted work. JWK is an advisory board member for Boston Scientific, Medtronic, Abbott, and Saluda Medical. GB reports consulting fees from Medtronic, Boston Scientific, and Saluda Medical outside the submitted work, and has a consulting agreement and is on the advisory board for Nevro Corp, Nalu Medical Inc, Abbott, and Boston Scientific. RST reports consulting fees from Medtronic, Nevro and Saluda Medical outside the submitted work. LP reports personal fees from Saluda Medical; is a member of the data monitoring board of Saluda Medical during the conduct of the study; and reports personal consulting fees from Medtronic and Nalu outside the submitted work. Members of the EVOKE study group report being employees of Saluda Medical. No other disclosures were reported.
 
um... whose message did i respond to?

it wasnt yours. i had no intention of implying that what you were doing was inappropriate, and if you took it that way, i apologize.

i guess i better be ultra specific.

i can see how, by misinterpreting some of these posts, someone could develop the concept of abusing the system by retrialing everyone ad infinitum -

It is Not Standard of Care to routinely retrial patients.

if someone decides to retrial a patient, they should document very clearly the reasons for the failure of the first trial and why a second trial is indicated

If I didn't get relief from one manufacturer's proprietary patented SCS waveform, and you said that I couldn't try another manufacturer's patented, proprietary waveform, I'd be pissed...
 
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It will take a few days to get through.

I mean just the COI:

Conflict of interest statement​

Competing interests: NM reports personal fees from Saluda Medical for acting as independent medical monitor for the EVOKE study during the conduct of the study; he reports receiving grants from Neuros and Mesoblast, as well as consulting as a medical monitor for Nevro, Vivex, Mainstay, and Vertos outside the submitted work. RL is an uncompensated consultant for Nalu, Saluda Medical, and Mainstay Medical and has stock options from Nalu and Saluda Medical obtained before 2019, not exercisable through the duration of his term as International Neuromodulation Society President and editor-in-chief of the journal Neuromodulation: Technology at the Neural Interface. TD reports personal fees from Saluda Medical during the conduct of the study; consultancy for Axonics, Abbott, Nalu, Vertos, SpineThera, Mainstay, Cornerloc, Ethos, SPR Therapeutics, Medtronic, Boston Scientific, PainTeq, Tissue Tech, Spinal Simplicity, and Avanos outside the submitted work. He is a minor equity holder for Saluda Medical, Nalu, SpineThera, Stimgenics, Vertiflex, Vertos, and Bioness and an advisory board member for Abbott, Vertos, Nalu, SPR Therapeutics, and Tissue Tech. LK reports receiving grants from Nevro, Neuros, Avanos, Medtronic, Neuralace, and Xalud Therapeutics and financial support from Nevro, Avanos, and Saluda Medical outside the submitted work. SL reports receiving grants and personal fees from Saluda Medical during the conduct of the study; he reports grants from Avanos, Boston Scientific, Nalu Medical, SPR Therapeutics, Averitas Pharma, Biotronik, SGX Therapeutics, and PainTeq, as well as consultancy for Abbott, Avanos, Boston Scientific, Nevro, SPR Therapeutics, Averitas Pharma, Biotronik, Nalu Medical, and PainTeq, outside the submitted work, as well as holding stock options for Nalu Medical. KA reports consultancy for Medtronic, Nevro, Boston Scientific, Nalu, Presidio, Biotronik, Mesoblast, Vivex Laboratories outside the submitted work. JP reports research and consulting fees from Saluda Medical during the conduct of the study; consultancy for Abbott, Medtronic, Saluda Medical, Flowonix, SpineThera, Vertos, Vertiflex, SPR Therapeutics, Tersera, Aurora, Spark, Ethos, Biotronik, Mainstay, WISE, Boston Scientific, and Thermaquil outside the submitted work; has received grant and research support from: Abbott, Flowonix, Aurora, Painteq, Ethos, Muse, Boston Scientific, SPR Therapeutics, Mainstay, Vertos, AIS, and Thermaquil outside the submitted work; and is a shareholder of Vertos, SPR Therapeutics, Painteq, Aurora, Spark, Celeri Health, Neural Integrative Solutions, Pacific Research Institute, Thermaquil, and Anesthetic Gas Reclamation. CH reports grants from Saluda Medical during the conduct of the study; consultancy fees from Genecentrix outside the submitted work. SC reports grants from Cleveland Clinic during the conduct of the study; and grants from Vertos, Mainstay, and Vivex outside the submitted work. SMF reports consulting fees from Abbott, Medtronic, Saluda, VertiFlex, Vertos, Surgentec, CornerLoc, Mainstay and Relievant outside the submitted work, has received grant for research funding from Mainstay, Relievant, Medtronic, Abbott, VertiFlex, Saluda, Nalu, CornerLoc, Aurora, Biotronik, and Stimgenics outside the submitted work, and has an equity position in SynerFuse, Aurora Spine, Thermaquil. SPR Therapeutics, Saluda, CornerLoc, PainTEQ, Stimgenics, Anesthetic Gas Reclamation, Neural Integrative Solutions, SpineThera, and Celeri Health. CG reports clinical trial funding from Saluda Medical during the conduct of the study; reports personal fees and other from SPR, and personal fees from Nevro, Nalu, Biotronik, and Boston Scientific outside the submitted work. PSS has received consultancy fees from Medtronic, Saluda Medical, Nalu, and Biotronic outside the submitted work, and has stock options from Saluda Medical and Nalu. JS reports personal fees from Nevro during the conduct of the study and personal fees from Saluda Medical and Boston Scientific outside the submitted work. TM reports research fees from Saluda Medical during the conduct of the study and personal fees from Nevro outside the submitted work. JC reports personal fees from Saluda Medical during the conduct of the study; personal fees from Abbott, Boston Scientific, Nevro, Medtronic, Mainstay, SPR Therapeutics, CornerLoc, PillNurse, Biotronik, and Vivex outside the submitted work; and stock from Mainstay, CornerLoc, and PillNurse. EP has received research support from Mainstay, Medtronic, Neuros Medical, Nevro Corp, ReNeuron, SPR, and Saluda Medical outside the submitted work, as well as personal fees from Abbott Neuromodulation, Biotronik, Medtronic Neuromodulation, Nalu, Neuros Medical, Nevro, Presidio Medical, Saluda Medical, and Vertos outside the submitted work. She holds stock options from SynerFuse and neuro42. JMH reports consulting fees from Abbott, Boston Scientific, Nevro, and Saluda Medical outside the submitted work. RR reports grants from SPR, Nalu and Nevro outside the submitted work,l fees from Presidio, and grants and personal fees from Boston Scientific and Saluda Medical outside the submitted work. JWK is an advisory board member for Boston Scientific, Medtronic, Abbott, and Saluda Medical. GB reports consulting fees from Medtronic, Boston Scientific, and Saluda Medical outside the submitted work, and has a consulting agreement and is on the advisory board for Nevro Corp, Nalu Medical Inc, Abbott, and Boston Scientific. RST reports consulting fees from Medtronic, Nevro and Saluda Medical outside the submitted work. LP reports personal fees from Saluda Medical; is a member of the data monitoring board of Saluda Medical during the conduct of the study; and reports personal consulting fees from Medtronic and Nalu outside the submitted work. Members of the EVOKE study group report being employees of Saluda Medical. No other disclosures were reported.

If you find it interesting let me know
 
COI are always interesting - to see who is getting paid off and is willing to sell their souls for $$$
My original question was asking comparisons of this study to another well recognized study in the field……as a side note with similar COI.
 
we dont compare studies based on COI. we evaluate each separately, factoring COI

the study appears to be well done.

the question is - what are you looking for?

if you are wondering "should i specifically look for closed loop system as opposed to open loop", then you can use this study to push for closed loop.

if you are wondering is SCS is viable in the first place, this study is not going to answer that question.


concerning aspect i have with the study - the data is not readily available. only the cherry picked numbers in the abstract.

for those conspiracy theorists - what does Saluda have to hide?

Data availability statement​

Data are available on reasonable request. Saluda Medical is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual, and trial-level data (analysis data sets), as well as other information (eg, protocols and Clinical Study Reports), provided the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications. These clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research and will be provided after review and approval of a research proposal and statistical analysis plan and execution of a data sharing agreement
 
we dont compare studies based on COI. we evaluate each separately, factoring COI

the study appears to be well done.

the question is - what are you looking for?

if you are wondering "should i specifically look for closed loop system as opposed to open loop", then you can use this study to push for closed loop.

if you are wondering is SCS is viable in the first place, this study is not going to answer that question.


concerning aspect i have with the study - the data is not readily available. only the cherry picked numbers in the abstract.

for those conspiracy theorists - what does Saluda have to hide?
 

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i believe it is a unique and strong study overall given the crossover design and blinding
 
i believe it is a unique and strong study overall given the crossover design and blinding
unique maybe, strong possibly, but as steve has mentioned, it is being promoted by those who have vested interest in someone buying the product.

the first was an independent monitor who was paid by Saluda.
RL has stock options from Saluda
TD gets personal fees. not much, only $8000 in 2022.
Pope got quite a bit, at least $40k in 2022
Li roughly $20k.
Levy only $1300 and Kapural $3700


Saluda paid out $34k in 2021 and that went up to $477K in 2022.

tell me if these names look familiar:

salulda payments.GIF
 
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I just looked at my numbers again. 50% implant rate so far on Saluda. So that’s a big drop off from Nevro/abbott numbers for my practice.

An interesting side note. I retrialed 3 of the failures with Nevro and they all failed those trials as well.

Very interesting.
 
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