New Concept for Chronic Pain Treatment

New Concept for Chronic Pain Treatment

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Whole-Body Muscular Relaxation is the Key

FDA-Cleared Class II OTC Medical Device

Image courtesy of Avacen Medical

Put your hand in this futuristic looking machine, which is about the size of a bread box, for 20 minutes and some really great things may happen. Pain dissipates, that foggy shroud disappears and joints move more freely. For many; eyelids become heavy, stress fades and some people actually fall asleep.

Profoundly Changes Chronic Pain Treatment

This unique FDA-Cleared muscular relaxation* device, the AVACEN 100, is the world’s first noninvasive device that is designed to allow patients to treat their entire body from a single convenient body location (the palm). Integrating the health benefits of a dry heat sauna and hyperbaric oxygen treatment, this may be the cost-effective solution chronic pain suffers have been searching for.

According to AVACEN Medical CEO and inventor, Thomas Muehlbauer, “The patented AVACEN Treatment Method (ATM) is an entirely new concept in chronic pain treatment through muscular relaxation by bathing the skeletal muscles with warm oxygenated and nutritious blood. With over 3,000 programmed microprocessor instructions, the company’s AVACEN 100 device manages the noninvasive and safe continued infusion of heat into the circulatory system using negative pressure and a conductive heat source (not LED or Infrared). It accomplishes this by taking advantage of a unique arrangement of blood vessels called the arteriovenous anastomosis (AVA’s) in the palm of the hand. The AVA’s normally act as the body’s radiator to dump excess heat to avert overheating. ATM manipulates the same AVA’s so they can be used as a portal to infuse heat into the circulatory system. When dilated and distended by ATM, blood flow through an AVA can be 1,000 times more than the smaller capillary.”

Muehlbauer added, “The key to ATM is the continued infusion of heat into the circulatory system when the body is at normothermia, approximately 98.6°F. The heat acts as a catalyst to thin the blood. The result is that the body must dissipate the unwanted heat by pumping the warmed and thinner blood through the skeletal muscles to reach the dilated heat exchange capillary network where it can be cooled by the ambient air. It should be noted that the level of heat is meticulously controlled so that it cannot induce heatstroke. Actually, the level of infused heat normally doesn’t even engage the sweat glands.”

“Overall, the ATM process increases microcirculation. The main functions of microcirculation are to deliver oxygen and nutrients and remove carbon dioxide (CO2) from the deep tissues. It also serves to regulate tissue blood flow.  This affects blood pressure and responses to inflammation, including edema (swelling), and chronic pain associated with numerous medical afflictions such as CRPS, Lyme Disease, Fibromyalgia, Rheumatoid Arthritis, Raynaud’s Disease and Carpal Tunnel Syndrome.”

“Understanding using the palm as a single point of treatment is really quite simple.  Basically, the heart pumps the warmed and thinner blood in the palm to all organ and muscle tissues. In other words, wherever blood flows, enhanced oxygen delivery and nutrition occurs. The overall benefits to the human aging process could be enormous!”

“For ATM to be effective the body must be at normothermia. Low body temperature is not healthy, as most of the important bodily enzymes** function best at or near normothermia. Therefore in the case of low core body temperature, the initial transfer of heat into the circulatory system is used to elevate the body to normothermia.”

* Muscle relaxation can reduce deep tissue pain which contributes to increased stress. Decreased stress can reduce the risk of strokes, heart attacks, ulcers, and mental disorders such as memory loss and depression. Reduced stress can also improve healing, enhance the body’s immune system, boost metal alertness, and even help with weight loss.

** Enzymes are large molecules, usually proteins, responsible for the thousands of chemical reactions that sustain life. Without proper enzyme function at the correct temperature, these chemical reactions will either take place too sluggishly, or not at all. Therefore it is absolutely critical to have normalized core body temperature for good health.

About AVACEN Medical: Over the last two years, AVACEN Medical has been awarded three U.S. and five International patents for its unique apparatus and methods that support its innovative medical process called the AVACEN Treatment Method (ATM). The company is dedicated to the innovation and design of safe, easy to use, noninvasive drug-free alternatives to treat chronic pain.

The AVACEN 100 is pending FDA approval for widespread pain related to fibromyalgia. It is FDA-Cleared as a Class II heat therapy system indicated for the temporary relief of minor muscle and joint pain and stiffness; the temporary relief of joint pain associated with arthritis, muscle spasms, minor strains and sprains; muscular relaxation. It is not available for sale for any non-cleared indication mentioned in this document.

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There are 14 comments for this article
  1. Dr joann tall at 8:53 am

    You only use one hand but it affects your whole entire body. It is truly a game changer for those who have any kind of pain or inflammation.

  2. Heather at 4:36 am

    You say it’s for the whole body but it looks like all you can get in there is a hand and half the arm.

  3. Thomas Muehlbauer at 12:01 pm

    Jurgen,

    Thanks for the question.

    The AVACEN 100 was just announced at PainWeek in Las Vegas. We are in the process of obtaining CE approval so we can market in the EU. This should happen 1st tr 2016.

  4. Jurgen Wolff at 4:39 pm

    It would seem trying this in a doctor’s office first would be useful. Can anyone provide any leads as to any doctors or clinics in the UK that offer this treatment? Thanks.

  5. Stenhance Finch at 7:01 pm

    I have been using the Avacen 100 for 2 years, and the results are life changing.

    After a back fusion, and collapsed disk in my neck from car accident, it is the one device in My life that I can use and get gentle relief from Inflammation immediately.

    Also for menopause great for sleeping and and helps keep
    My ADD in focus, Thanks Avecen,you have changed my life. I recommend it to everyone!!!!!

  6. Dr. Joann Tall at 5:32 pm

    I have been using the Avacen for almost three years ago. I have chronic migraines and have tried everything that western medicine has to offer as well as many alternative modalities. Nothing really helped my headaches and over the last few years I had gotten to the point where my life was severely compromised and I was having migraines almost daily.
    I heard about it from a good friend of mine who is a rheumatologist and had good experiences of his own. Within a month I experience dramatic results. I went from28 to 11 migraines the second month, then 9, then 6, then for the last almost three years I have between 2-6 migraines a month.
    Even more wonderful is that I no longer have some of the problems that I had before concerning the migraines. I am a type 1 diabetic and could not take short acting insulin due to an immediate response – within ten minutes I would get an acute migraine. Within the first month of treatment, this completely stopped and I have been using short acting insulin since with no problems.
    I have referred this machine to many friends and patients and most have been very happy with it’s effects. It has no side effects and in the field of medical machinery it is quite reasonable. When you calculate the cost of medication for your health problem and then add in the potential for side effects and their cost; this seems to be a bargain to me.
    In my case, I calculated that I had spent thousands of dollars a year on recommended treatments *both western and integrative to no avail. This machine has changed my life and I am very grateful.
    * biofeedback,neurofeedback,transcutaneous magnetic stimulation,many prescription drugs both preventitive and abortive,acupuncture,acupressure,meditation,hypnosis done by a medical professional,trigger point therapy, physical therapy,chiropractic,cold laser treatment, western and eastern herb therapy of all types, dietary changes specific for migraine,yoga, pilates,meditation,visualization,etc.

  7. Thomas Muehlbauer at 5:19 pm

    Dear Doc Anonymous,

    Your post was very educational but please let me point out that this is not an inexpensive LED device. Its the same device used in clinics.

    When the hand, enclosed in a special patented mitt, is placed inside the vacuum chamber, the microprocessor manages the application of negative pressure and heat to safely increase the temperature and volume of blood flowing through the high volume AVA’s. It is important to note that the application of heat without managed negative pressure is ineffective.

    We do have a trial program.

    As for your point that this is an FDA substantially equivalent device: First of all the 510(k) process is expensive and intensive when it comes to safety. Furthermore unless you have a new device or intended use the FDA requires the SE process be used.

    That being said, in January AVACEN filed a De Novo application for approval based on our fibromyalgia clinical trials.

    For a better understanding see: https://avacen.com/understanding-the-avacen-100

    Please don’t take this post as a defensive response. I, like you, are only interested in making sure that every possible legitimate treatment is made known to those who desperately need it.

  8. Thomas Muehlbauer at 4:33 pm

    Deb,

    We worked hard to get OTC clearance (had to do an extra usability study).

    Not needing a prescription might also be a clue that it is a very safe treatment.

    Unfortunately at this time, insurance does not cover this medical device. Even though the AVACEN 100 brings relief to the suffering of patients that have found no other remedy for their pain; in the eyes of the insurance companies, the AVACEN 100 is currently considered experimental technology.

    The necessary studies to qualify the AVACEN 100 to be covered by insurance will cost millions of dollars and could take many years. Therefore, we have decided not to take the reimbursement path for the time being in order to make the AVACEN 100 available today at a reduced cost (such studies could add 75% to the eventual device cost).

    If you have a Healthcare Flexible Spending Account (FSA) or Health Savings Account (HSA), you may be able to purchase the AVACEN 100 using that option.

    We understand that the $1995 AVACEN 100 is a significant investment for you. Our previous product, the VP106, which also used the AVACEN Treatment Method (ATM), sold for $3995. Millions of dollars have been spent to develop the AVACEN 100 (a second generation ATM device). We have worked hard to reduce the cost as much as reasonably possible.

    According to published studies, adjusted for 2015 medical costs, the average chronic pain patient spends $2,858 annually in out-of-pocket costs (this will continue to increase). The AVACEN 100, if effective for you, can significantly reduce the cost of medications and doctors’ visits.

    The cost of our $1995 device divided by its 5 years useful life equates to a monthly cost of around $33.25 a month, or a little over $1 a day, which we think you’ll agree is very reasonable.

    To make purchasing the AVACEN 100 more affordable, we have partnered with PayPal Credit (select during on-line check-out), allowing the device to be purchased for approximately $59 a month over 48 months. When you consider the $238/mo. ($2,858/12) in out-of-pocket costs mentioned above, $59/mo. is a significant out-of-pocket savings.

    Even though some people with chronic pain may have poor credit, almost all of them have a friend or relative that is willing to buy our product for them using PayPal Credit.

  9. Doc Anonymous at 3:46 pm

    The Avacen is registered with the FDA as being “substantially equivalent” to other devices that have received FDA approval. That kind of registration allows the company to market the device without doing any actual patient studies. It is registered as a “heat treatment” device.

    Since it is a heat treatment, the question is whether heat is going to be delivered in a manner that is beneficial. I do not object to this device per se, but there may be less expensive ways of delivering the same quantity of heat. From a physical science perspective, any device that delivers heat to the hand will warm the blood in the AVAs.

    And then there is the issue that “Pain”, like all sensations, is the brains interpretation of a set of or series of electronic signals arriving in parts of the brain. It is possible that a slight increase in the temperature of the circulating blood may affect the electronic signal transmission. But at $2000 for the device, it seems to me that patients should have the right to “Try before You Buy” option. That way the patient will also have an idea about the duration of the effect of the treatment.

    Here is the link to the FDA document for this device:

    http://www.accessdata.fda.gov/cdrh_docs/pdf13/k133981.pdf

  10. Gracie Bagosy-Young at 2:13 pm

    I have one! I have CRPS, Lyme Disease, and Raynaud’s, which leaves me constantly frozen. I love my AVACEN! It reduces my allodynia (hypersensitivity), warms me head to toe, and makes me very sleepy. I didn’t think it looked like much when i first saw it. I thought it would just warm up one had at a time. I was wrong. It is almost like it gives me a fever, except I don’t sweat. It is difficult to explain. But unless I am in the bath tub, it is the only thing that cools the ice in my body!
    It isn’t cheap. But they do have a very generous payment plan. $45 per month is far less than I have ever paid for any other treatment.

  11. Barbara W at 2:10 pm

    Idk if my CRPS would like this. Because my palms are a 8-9 pain most days. I LIVE WITH FIRE. I would probably spontaneously combust.

  12. Jan Mollet Evans at 2:01 pm

    I’ve used the Avacen 100 for 5 years, and I simply wouldn’t be able to function normally without it. For years, I had suffered from chronic sinus problems and low body temperature, along with a variety of other seemingly unrelated symptoms. When I was finally diagnosed with fibromyalgia, I thought things would get better, but the drugs the doctor prescribed for the pain left me feeling constantly tired and disoriented without much pain relief. Then, I tried the Avacen’s predecessor device, the VP106. Within 6 weeks of starting to use it for less than an hour a day, I was able to stop taking all the drugs! I was a new person; I could do everything I wanted to do, but couldn’t for many years before using the device. Long walks, shopping trips, and travelling all became possible for me again. The new Avacen 100 came along 2 years ago — at half the price of the old machine — and it was so much easier to use, so I switched to it and I couldn’t be happier. Once or twice a day, 30 minutes at a time, and I’m pain-free and ready to go. The cost of the Avacen 100 is low when compared to the cost of prescriptions, doctor’s visits, and time lost from work (and from living a full life)! Many of my friends and family now use this device for arthritis and a number of other different conditions — I recommend it for everyone looking for relief from their aches and pains!

  13. Deb at 1:26 pm

    but who can afford $2000 for something that you don”t need a script to get? if you don’t need a script then i’m sure insurance won’t cover it either.

  14. cynthia at 11:20 am

    does anyone have experience with one of these? i have chronically low body temp, which is what struck me about this….but it’s expensive…just wondering if anyone has tried it?