Burst stimulation

[epidural man]

Is anyone routinely doing burst stimulation?

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[lonelobo]

Is anyone routinely doing burst stimulation?

Well I assume most had to Google it as well, so I would say no one does this routinely

 

[deleted472101]

Isn't that newer in the pipeline?

 

[NJPAIN]

Aren't we awaiting FDA approval ?

 

[NOSfan]

Haven't utilized thus far, but here is an abstract from this past week's NANS conference.

Patients Reporting Moderate-Severe Pain Using Tonic Spinal Cord Stimulation Reported Mild-Moderate Pain Using Burst Stimulation (93)
Anthony Espinet,et. Al

Introduction: Tonic spinal cord stimulation (SCS) delivers a consistent stream of pulses, and burst stimulation delivers groups of pulses separated by dormant intervals. Alternative simulation modes, like burst, are posited to offer salvage pain relief to patients who are not responding well to tonic SCS. The purpose of this analysis was to examine the change in pain intensity for burst SCS versus tonic SCS in relation to the pain severity patients reported while using tonic SCS.

Methods: At 4 IRB-approved sites, 22 patients using tonic SCS for at least 90 days signed informed consent and received burst SCS programming for 14 days. Pain intensity, using the Visual Analog Scale (VAS), was assessed at the start of the study, while patients were using tonic stimulation, and at the end of 14 days of burst stimulation. The primary study findings were previously reported. For this exploratory analysis, patients were categorized into 2 groups according to VAS scores reported while using tonic SCS (VAS≤47 or VAS>47), corresponding to mild to moderate or moderate to severe pain, respectively, based on metrics defined in the literature. The percentage of change in VAS between tonic and burst SCS was computed for each patient. Descriptive statistics are provided.

Results: During tonic stimulation, 8 patients (38%) reported mild to moderate pain, and 13 patients (62%) reported moderate to severe pain. After 14 days of burst SCS, patients with mild to moderate pain reported an average VAS decrease of 38% (from a mean of 31.5mm to 20.6mm), and patients with moderate to severe pain reported an average VAS decrease of 51% (from a mean of 67.9mm to 32.7mm). Eleven of the 13 patients (85%) with moderate to severe pain while using tonic SCS reported VAS scores in the mild to moderate range after 14 days of burst SCS.

Conclusions: A majority of patients with severe pain while using tonic stimulation reported mild to moderate pain intensity after 14 days of burst stimulation. Our results indicate that burst SCS may provide enhanced pain relief for patients who are unable to achieve mild to moderate pain using tonic stimulation. Additional, adequately powered, studies are needed to verify these preliminary results.

Disclosures: A. Espinet: This clinical research study was sponsored by St Jude Medical., Dr. Espinet is a paid consultant for St Jude Medical. P. Courtney: This clinical research study was sponsored by St Jude Medical., Dr. Courtney is a paid consultant of St Jude Medical. B. Mitchell: This clinical research study was sponsored by St Jude Medical., Dr. Mitchell is a paid consultant for St Jude Medical. M. Russo: This clinical research study was sponsored by St Jude Medical., Dr. Russo is a paid consultant of St Jude Medical. A. Muir: This clinical research study was sponsored by St Jude Medical., Dr. Muir is a paid consultant of St Jude Medical. P. Verrills: This clinical research study was sponsored by St Jude Medical., Dr. Verrills is a paid consultant of St Jude Medical. K. Davis: This clinical research study was sponsored by St Jude Medical., Employee of St Jude Medical.

 

[epidural man]

Aren't we awaiting FDA approval ?

Yes for high frequency stimulation. I think the batteries available now are capable of doing burst stimulation but the data seems to indicate it is as effective as high stimulation.

We just had an excellent lecture on the subject - hence my question. I had very little info on it prior to this lecture.

It sounds very interesting, as does the high frequency stim.

Apparently, there was a LOT of discussion about high frequency and bursts stimulation at NANS this year.

Also, my partner who went also told me there was some discussion on neruomodulation modulating immune system....pretty cool stuff.

 

[NOSfan]

You heard it here first.....this company is going to significantly impact the SCS market:

http://www.stimwave.com/

 

[PinchandBurn]

You heard it here first.....this company is going to significantly impact the SCS market:

http://www.stimwave.com/

I saw this somewhere. If this is true . I can't see why anyone would use anything but it....it would be less risky to implant.

 

[Aether2000]

The technology is obsolete before being introduced due to the lack of MRI compatibility. We have a duty to patients to assure that we are not restricting and perhaps worsening patient care by other specialties for our own myopic hell bent need to implant archaic non-upgradable pain reducing devices. When a SCS device becomes total body MRI compatible, THEN it is up to par. We have a few patients that have come to us recently considering litigation against the physician that implanted the non MRI compatible units but were never offered or told about MRI compatible SCS, and this has negatively affected their healthcare since other physicians are not able to obtain adequate diagnostics to make a determination on a course of action. The solution: either implant the available total body MRI compatible unit or wait until the technology desired is given FDA approval for such.

 

[epidural man]

ALagos, I hear what you are saying.


I'm not sure I agree. Most things can be seen with ct or other imaging modalities. If an MRI is needed, the leads can be removed and replaced after the scan. Leads are relatively cheap.

There are a lot of things to consider with companies besides just one thing (MRI compatibility). There are other subtle differences that a physician may think are important enough that it outweighs that other single issue.

 

[Aether2000]

Unfortunately they are no longer cheap to patients that have a $6500 deductible plus 30% under mandatory obamacare standards. But is the generator approved for mri anywhere in the body when the leads aren't? And since these patients are being told the ct is inadequate they are stuck unless they want to fork over $8000 out of pocket for lead removal and replacement all because their implanting doctor never gave them a choice (informed consent issues).

 

[emd123]

The technology is obsolete before being introduced due to the lack of MRI compatibility. We have a duty to patients to assure that we are not restricting and perhaps worsening patient care by other specialties for our own myopic hell bent need to implant archaic non-upgradable pain reducing devices. When a SCS device becomes total body MRI compatible, THEN it is up to par. We have a few patients that have come to us recently considering litigation against the physician that implanted the non MRI compatible units but were never offered or told about MRI compatible SCS, and this has negatively affected their healthcare since other physicians are not able to obtain adequate diagnostics to make a determination on a course of action. The solution: either implant the available total body MRI compatible unit or wait until the technology desired is given FDA approval for such.

Another easy solution: trial but don't implant. Leave to the implanter to deal with.

 

[ampaphb]

Unfortunately they are no longer cheap to patients that have a $6500 deductible plus 30% under mandatory obamacare standards. But is the generator approved for mri anywhere in the body when the leads aren't? And since these patients are being told the ct is inadequate they are stuck unless they want to fork over $8000 out of pocket for lead removal and replacement all because their implanting doctor never gave them a choice (informed consent issues).

Mike, you answered your own question. You dont need to implant only MRI compatible devices. You only need to make sure the patient is fully informed prior to moving forward with the procedure.

 

[Ducttape]

Wasnt sure which thread to put this in, but in case anyone missed it, or was really interested...

http://www.news-medical.net/news/20...elivering-HF10-therapy-gets-FDA-approval.aspx

Nevro's Senza spinal cord stimulation system for delivering HF10 therapy gets FDA approval
Published on May 10, 2015 at 12:03 AM·No Comment

Nevro Corp. (NYSE: NVRO), a medical device company that is providing innovative evidence-based solutions for the treatment of chronic pain, today announced that it has received approval from the United States Food and Drug Administration (FDA) for its Senza spinal cord stimulation (SCS) system. Nevro also announced that it will now be releasing financial results for the first quarter of 2015 before market open on Monday, May 11, 2015. The Company will be hosting a conference call beginning at 8:30 a.m. Eastern Time to discuss both the FDA approval and first quarter operating results on Monday, May 11, 2015, in place of the conference call previously scheduled in the afternoon of the same day.

The Senza SCS system, which delivers Nevro's proprietary HF10 therapy, is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain.

The Senza system delivering HF10 therapy has experienced strong adoption in Europe and Australia over the past 5 years. With this FDA approval, patients in the U.S. suffering from chronic pain will have the opportunity to experience the significant benefits of HF10 therapy. FDA approval of Nevro's Senza system highlights the unique nature of the technological innovation:

• HF10 therapy is the only SCS therapy approved by FDA with superiority labeling;
• HF10 therapy is the only SCS therapy indicated by FDA to deliver pain relief without paresthesia (a constant tingling sensation that is the basis of traditional SCS);
• HF10 therapy is the only SCS therapy approved by FDA to be used without patient restrictions on motor vehicle operation while receiving therapy; and
• The Senza system is the only implantable SCS system approved by FDA with labeling for 3T conditional MRI compatibility.

The Senza system was the subject of the SENZA-RCT pivotal study, a ground-breaking study that was the first to directly compare SCS therapies. The multicenter study was conducted across 11 U.S. clinical trial sites, comparing the safety and effectiveness of HF10 therapy to traditional SCS therapy. The study enrolled 241 patients, making it the largest prospective randomized SCS study ever conducted to assess the treatment of chronic back and leg pain.

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"My fellow investigators and I have eagerly awaited the approval of the Senza SCS system," said Dr. Leonardo Kapural, lead investigator for the SENZA-RCT pivotal study from Wake Forest University Baptist Medical Center. "The results of the study showed that HF10 therapy provides better pain relief and nearly twice the response rate of traditional SCS, representing a tangible advance in chronic pain management. HF10 therapy will allow me to help more patients in my practice by addressing back pain in addition to leg pain. And, with HF10 therapy I can for the first time focus on providing pain relief to my patients instead of managing paresthesia, which is a paradigm shift for my pain practice."

The labeling for the Senza system and HF10 therapy was based on the SENZA-RCT clinical trial, where HF10 therapy was meaningfully superior to traditional SCS therapy for back and leg pain, including superior response rates, pain relief, and functional outcomes. Superiority was demonstrated in the primary and all secondary endpoints including at every measurement time point throughout the 12 month follow up.

"We are grateful to the inspiring dedication of the clinical investigators, their study coordinators, and patients involved in the SENZA-RCT study, as they collectively have paved the way for this therapy to help those suffering from debilitating chronic pain," said Michael DeMane, Chairman and Chief Executive Officer of Nevro. "The Nevro organization is prepared to initiate a responsible rollout of HF10 therapy to the U.S. pain management community and the patients they serve to ensure we deliver the clinical outcomes that are the foundation of our therapy and company."

 

[drrosenrosen]

My SJM rep has told me they're expecting conditional MRI compatibility to come down the line soon as well. StimWave and Nevro both seem to be MRI compatible up to 3.0T. There are other conditions that are more technical than I understand about MRI. I don't know if they functionally reduce the utility of the diagnostics. Can anybody weigh in? Nevro's RCT also included superiority as an endpoint, so they can say with the FDAs blessing that their device is superior to Boston's as far as pt outcomes.

 

[drrosenrosen]

Reading over Nevro's conditions more thoroughly, it looks like head and extremity only. Not sure about StimWave. So that leaves MDT as the only company still good for full body MRI. Which sucks, because I like their product least of all the others in every other way. I know SJM is coming out with burst mode for their new upgradeable IPG.

 

[Ducttape]

My understanding is that high frequency stim is possible in new SJM units

 

[epidural man]

Regarding MRI compatability....

Has anyone with the medtronic MRI compatible device had their patient scanned (body scan) with a device? Did the radiologist actually do it?

Here are my concerns about all this MRI hoopla. First, I think radiologists will not trust FDA and medtronic's rubber stamp of approval and will likely still refuse to do the scan with a device implanted. Next, only 3% of implanted patients get explanted for their required MRI (thats a very small number to justify inferior technology), and finally - at least in our hospital, we only have 3T scanners anyway so they can't get scanned anyway regardless of the system used.

 

[olafa]

a million and one precautions
http://stimwave.com/products/freedom-4-scs-system

 

[Lehite]

Anyone using HF-10 yet?