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Thread: Nick Terrafranca from Neurorecovery Technologies presentation

  1. #11
    Quote Originally Posted by Matt Bellman View Post
    This is a common misconception. You can't just ignore regulatory requirements by making no claims about health benefits. It's more complicated than that. That would be like saying you could sell guns to people while ignoring the regulatory requirements, simply by putting a sticker on it that says, "This is definitely NOT a gun."

    The companies that do sell medical devices without following regulatory requirements are breaking the law. However, like any law enforcement agency, the FDA has a limited amount of resources, so it has to put its efforts towards ensuring that the biggest risks are covered. TENS devices are very low risk devices. FES bikes are a little riskier. Implanted stimulators are extremely risky. Transcutaneous spinal cord stimulators fall somewhere between TENS units and implanted stimulators, in terms of risk. The problem is, no one can say definitively yet where on that spectrum they're located. Therefore, clinical trials are being conducted to answer that question and to determine whether the risks outweigh the benefits.

    Doctors generally don't make money off prescriptions (anti-kickback laws), and healthcare hardly pays for anything these days. It's much more a safety and efficacy issue than a financial one.
    I didn't say ignore, what I said was
    it could go through a different process which would take no time at all

  2. #12
    Quote Originally Posted by Matt Bellman View Post
    Tommy's probably referring to some of the transcutaneous designs that pass current all the way through the torso. These do require more power than your standard off-the-shelf stimulator has.
    Indeed!

  3. #13
    Combine this treatment with Jerry Silver's peptide treatment and a whole lot of SCI folks would get their lives back.

  4. #14
    Quote Originally Posted by niallel View Post
    I didn't say ignore, what I said was [/I][/COLOR]
    Sorry, I must have missed your meaning. What different process are you thinking about?
    Co-founder & CTO of MYOLYN - FES Technology for People with Paralysis - Empowering People to Move

  5. #15
    Quote Originally Posted by Matt Bellman View Post
    Sorry, I must have missed your meaning. What different process are you thinking about?
    Maybe start with the General Wellness category, and if that doesn't work then the exceptional use category, so we can get our hands on them before full FDA/EU approval.

    Funny you should mention guns, apparently anyone can buy one and I think they are slightly more dangerous that e-stim!
    Last edited by niallel; 07-23-2018 at 04:11 AM.

  6. #16
    Quote Originally Posted by niallel View Post
    Maybe start with the General Wellness category, and if that doesn't work then the exceptional use category, so we can get our hands on them before full FDA/EU approval.
    Good suggestions. Unfortunately, no matter how we slice it, these devices will be considered at least moderate risk (Class II), and the FDA is probably classifying them as De Novo (Class III, effectively higher risk because of uncertainty). General Wellness and other express lanes are for devices that are demonstrably low risk. Even if this technology is ultimately determined to be low risk, it still has to be demonstrated through clinical trials, and that's the part that takes forever.
    Co-founder & CTO of MYOLYN - FES Technology for People with Paralysis - Empowering People to Move

  7. #17
    Quote Originally Posted by Matt Bellman View Post
    Good suggestions. Unfortunately, no matter how we slice it, these devices will be considered at least moderate risk (Class II), and the FDA is probably classifying them as De Novo (Class III, effectively higher risk because of uncertainty). General Wellness and other express lanes are for devices that are demonstrably low risk. Even if this technology is ultimately determined to be low risk, it still has to be demonstrated through clinical trials, and that's the part that takes forever.
    Got the name for the exceptional use wrong, its the FDA Expedited Access Pathway Program
    https://www.fda.gov/medicaldevices/d.../ucm441467.htm

    The FDA intends to notify the sponsor of its determination in writing within 30 days of receipt of a request for EAP designation.
    So it doesn't have to go through the full clinical trials if its approved for this.

    The device is more like a Class II. Other transcutaneous stimulators for pain have been classified as Class II already. Internal stimulators have been classified as Class III.

  8. #18
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    Quote Originally Posted by Matt Bellman View Post
    Tommy's probably referring to some of the transcutaneous designs that pass current all the way through the torso. These do require more power than your standard off-the-shelf stimulator has.
    Uh, not exactly. The human body is conductive. It's not as conductive as metals but close to the conductivity of water. For electromagnetic fields to penetrate conductors requires lower frequencies, not power. Skin depth in any conductor is inversely proportional to frequency, independent of power. More power might get you better results, but, even in that case, pulse width will be the more important parameter.
    Finally, as someone who has experienced a wide variety of stim devices, including NRT's, I can tell you it's not monstrously powerful. I have replicated the NRT electrode arrangement with other FES devices and the abdominal contraction from the NRT device is no stronger.
    T3 complete since Sept 2015.

  9. #19
    Quote Originally Posted by Mize View Post
    Uh, not exactly. The human body is conductive. It's not as conductive as metals but close to the conductivity of water. For electromagnetic fields to penetrate conductors requires lower frequencies, not power. Skin depth in any conductor is inversely proportional to frequency, independent of power. More power might get you better results, but, even in that case, pulse width will be the more important parameter.
    Finally, as someone who has experienced a wide variety of stim devices, including NRT's, I can tell you it's not monstrously powerful. I have replicated the NRT electrode arrangement with other FES devices and the abdominal contraction from the NRT device is no stronger.
    Lower frequencies? The NRT device has a 30Hz frequency with a 10,000Hz carrier frequency. Would that be classified as low? I don't know, as I'm not sure how the carrier frequency would affect that classification.

    You're correct pulse width is a very important parameter. What is the pulse width of a TENS unit? I'm not trying to be antagonistic...I honestly don't know. I imagine the NRT device is capable of a much higher pulse width.

    When you say "powerful", are you referring to the amplitude of the frequency? Again, as far as I know, the NRT stimulator is capable of a higher amplitude than anything currently on the market - if I recall correctly, they have cranked it up to 180 mA with some people. What amplitude are most TENS units capable of? Again, I'm just asking because I don't know.

    The abdominal contraction from the NRT device is not indicative of the amplitude or power. I have replicated the electrode placement with other devices on myself as well, and gotten an abdominal contraction and/or lower back muscle contraction. Trunk muscle contractions are just a side effect of the main goal of the NRT and other motor-enabling transcutaneous stimulators, which is to alter the excitability of spinal neurons (not axons, but the cell bodies of neurons themselves) that current stim devices can't get to.

  10. #20
    Quote Originally Posted by niallel View Post
    Got the name for the exceptional use wrong, its the FDA Expedited Access Pathway Program
    https://www.fda.gov/medicaldevices/d.../ucm441467.htm
    You're right. This technology could satisfy the criteria for the EAP program and get to market sooner. Ultimately, it comes down to risk vs. benefit and it's up to the FDA to decide.

    Quote Originally Posted by Mize View Post
    Uh, not exactly. The human body is conductive. It's not as conductive as metals but close to the conductivity of water. For electromagnetic fields to penetrate conductors requires lower frequencies, not power. Skin depth in any conductor is inversely proportional to frequency, independent of power. More power might get you better results, but, even in that case, pulse width will be the more important parameter.
    Finally, as someone who has experienced a wide variety of stim devices, including NRT's, I can tell you it's not monstrously powerful. I have replicated the NRT electrode arrangement with other FES devices and the abdominal contraction from the NRT device is no stronger.
    "Powerful" wasn't the best word choice, though it was the most colloquial. As I'm sure you know, electrical power is the product of voltage and current. In this context, the question was about whether or not a typical electrical stimulation device, as may be commonly purchased at a pharmacy or other retailer, would be able to generate voltages high enough to pass a therapeutically significant amount of current through the target tissues. Human tissue, especially skin and fat, have a high impedance, enabling alternating currents to pass through more easily than direct currents (part of why we all use alternating waveforms), so waveform and frequency do matter (though probably less than expected in this case).

    I think the most important statement here is the one based on your own experience that, under similar conditions, your body responded to the NRT device as it would have to other FES devices. What other FES device(s) did you try it with?

    An interesting side question: to what extent do you think the proprietary characteristics of the NRT device matter in terms of the ultimate outcomes being sought here? In other words, could someone get 95% of the same benefits seen with the NRT device while using an affordable, off-the-shelf stimulator that's already available? Or is it maybe only 5%?
    Co-founder & CTO of MYOLYN - FES Technology for People with Paralysis - Empowering People to Move

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