Avacen 100 Device for Relieving Fibromyalgia Pain Earns EU Marketing Approval

Avacen 100 Device for Relieving Fibromyalgia Pain Earns EU Marketing Approval

Avacen Medical has received approval to market its Avacen 100 device, which decreases pain associated with fibromyalgia (FM), in the European Union.

 

Avacen 100 is an FDA-approved, drug-free, non-invasive device that heats the circulatory system to promote muscle relaxation and reduce pain.

Placing the hands on the device’s heating pad for 10 to 30 minutes increases body temperature. This decreases activity in the part of the nervous system that controls muscles, relieving muscle and joint pain.

EU approval was based on a clinical evaluation report covering 22 FM patients (NCT01619579). The Avacen 100 reduced pain in all of them.

Researchers used three scales — the Widespread Pain Index (WPI) Score, Tender Point Count (TPC) and Symptom Severity (SS) Score — to measure results after four weeks of treatment.

Those using the device showed a 40 percent reduction in their widespread-pain-index score, and a decline in average tender point counts from 15 to 9.

Thomas Muehlbauer, Avacen’s CEO, said in a news release that the Avacen 100 is “the only [over-the-counter] medical device on the market today able to provide non-invasive, rapid whole body treatment, using a single point of contact.” It is an “ideal drug-free and safe alternative for relief of muscle and joint pain,” he said.

“The most exciting aspect of CE approval is that the E.U. market has shown high demand and acceptance for innovative new alternatives to pharmaceuticals for treating chronic pain,” Muehlbauer added.

FM is characterized by chronic muscle pain, fatigue, sleep problems, and painful tender points. The National Fibromyalgia Association estimates that the disease affects 200 million to 400 million people worldwide. In Europe, 14 million people are believed to have it, according to the European Network of Fibromyalgia Associates (ENFA).

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Joana brings more than 8 years of academic research and experience as well as Scientific writing and editing to her role as a Science and Research writer. She also served as a Postdoctoral Researcher at the Center for Neuroscience and Cell Biology in Coimbra, Portugal, where she also received her PhD in Health Science and Technologies, with a specialty in Molecular and Cellular Biology.

21 comments

  1. Denise Bault says:

    Pardon my skepticism. Let’s see…it’s cold in Europe. You put your hands in a device that warms them up for thirty minutes and everything is all better. Things that make you go, “Hmmmmmm.”

    • Tim Bossie says:

      Yeah… we get what you’re saying. Warmth does help, especially in a cold environment. However, this trial didn’t just take place in the winter months. 🙂

    • Trish parvu says:

      They really don’t get it! We all need to band together and hold our government accountable for making people lab rats while we suffer terribly in pain. The pain medication is there why do we have to beg for it????

  2. StevefromMA says:

    Jeez, That is good news but also depressing as it was one more treatment I failed. I can’t believe it worked for all 22 people. I tested the hell out of it and the company was very good about helping me with the trial. It’s definitely worth a trial for fm pts. I am trying out a vagus nerve stimulator now, does not work for me either. My guess is that my brain is too damaged after 30 years of fm to be repaired and I am afraid that will die in pain with this disorder.

    • Tim Bossie says:

      Hey Steve, sorry that this device didn’t work for you. There are some that do not respond to nerve stimulation or manipulation in helping to ease their pain.

  3. Wendy honor says:

    hi never written about this before so here it goes into I’m in UK feel like Steve above that 1 day will just die with pain I am 53 and was told I had fallen in 2006 when most doctors had never heard of it. when I lived in Oxfordshire hospital there were fantastic they instead of pumping with drugs gave me injection in my spine which eased it enough to work part time when I moved to Hertfordshire it’s been a nightmare been to pain consultants there answer even though I told of success with injections is for the last 10 yrs to be on. morphine tabs 40mg 4 x day diazepam 5mg 4xday co-codamol 30x500mg 4 x daily amytriptyline 10mg 20mg morning 40 at night promethazine tabs 2 x night new 1 for depression mirtazapine 45mg at might my GP is only 1 fighting for me to come off thEverything drugs and at least try injections hospital answer won’t get funding for injection for fb as no cure so won’t pay for it I can’t pay for it as widowed and on disability. when you are treated like this it makes you want to give up even more.
    I originally injured my back in 2001 and my pain always is across lower back left leg and foot my neck left arm is suffer severe shakes in both hands all of these have got worse as yrs gone by but I am not totally convinced I have fb I forget words and things I want to say but that always happens when pain worse and have not slept pain is always like a headache across lower pain and then with no warning this excruciating pain will shoot across my back like a knife being pulled in and out in can’t move takes my breath away have to increase morphine to ease pain now because this 1 consultant said it’s fb not anything else even though not been tested hospitalwill not exam or test for anything else I feel like Steve that I will just die in pain one day as once you have been given the fb tag no medical profession wants to know just give you more drugs that are probably killing me anyway and go away I am sorry this is so negative and would totally understand if you didn’t post it as there are others on this site with there own struggle with fb and I would not want them to become more disheartened by this blog thank you wendy

    • Deb says:

      You describe a lot of Parkinson symptoms..treatable by putting the Dopamine back into the region of the brain. It’s also not uncommon for folk to suffer not only Fibro but other disruptive and painful conditions even prior to Fibro sneaking up on them.. Take care..Go see a good doctor or specialist and ask to be assessed fully.

    • Rhonda says:

      Wendy, I am a 54 year old woman. I have had fibro for over 15 years now. I too have a back injury from a surgery that was botched, didn’t work and made it worse eventually. The first pain management dr. had me on Morphine, and muscle relaxers. All I did was sleep, I had two children still at home and my quality of life was horrible. I finally hit rock bottom and had my husband take me to our local hospital. The doc there helped me get admitted to a facility that was able to get me off the morphine. The people that worked with me at this facility told me that the morphine I was on was equal to street heroin. I’m telling you this because once I stopped taking the morphine my life changed so much for the better. I found another pain management dr that really cared and he helped me find the right pain medicines at the right dosages. I believe that because of my back injury not being able to be fixed is the cause of the fibromyalgia. It’s like my body is always under attack and traumatized. So I’ve learned to deal with it the best I can. I take 2 pain meds for my back, and a muscle relaxer to help me at night. I also take an anti-depressant because it helps IMMENSELY with the pain. Yes I have days that I stay in bed. But I have a job that keeps me moving every day. I only work 2 hours but I am on a schedule so I’m forced to be somewhere at a certain time which helps me get out of the house. I feel better when I go do something. Even if it’s just a trip to the store. I really hope that you can start to enjoy your life again very soon. And I am always here if you want to chat. Hugs! Rhonda in Ohio, USA.

    • Rosana Drummond says:

      Wendy, I went through something like this about 10 years ago. I had excrutiating pain all over my body, like knifes being cutting me. I went to see several doctors and all of them said that it was FB. But it was impossible to cope with that. Then I went to a Pain Clinic and there they put me on trillions of tests and they discovered that I was beginning an autoimmune disease. I was put on several medications including an antimalarial and corticoids, with phisiotherapy and psicotherapy. And slowly I begin to recover from that hell! so, have you tested for autoimmune diseases? reumathologic diseases other than FB? if not, go for that. And God help you find the better treatment for your pain.

  4. PAMELA BERGMANN-KNEBEL says:

    Wow! $2300; that’s a lot for something that may not help. For now I will stick with what I’m doing, meds, TENS, rest, diet.

    • Tim Bossie says:

      Yes… that is A LOT of money! The key, though, is to do exactly what you’re doing. Whatever works. Rest, diet, activity, TENS (is great), meditation, acupuncture… whatever. Fibro is universal in the pain, but not so much in what works for everyone.

  5. Jill Konen says:

    It’s great if it works for some people. In the US you can buy hand warmers to put in your pockets or gloves etc. what would the difference be?? I was always so cold!! My heart Dr thought I had Raynauds. Once I got my new pacemaker everything changed!! I’m actually tearing off my covers! And my hands are much warmer. Oh I had to get a new one cause I was using my battery up too fast. My left side was not functioning well. So they had to put in a 3rd wire. I’m off on another tangent but sometimes it could be something more serious!!

    • Tim Bossie says:

      Hi Jill… thank you for your comment. You’re right, hand warmers are a godsend for many. Don’t worry about tangents, we like tangents. They keep us thinking and seeing things from a different view.

  6. Wendy says:

    I use a lot of heat. I sleep on top of an electric blanket, use a heated throw on my couch (much bigger than a tiny heating pad), take epsom salts baths, and warm up my cold hands doing dishes. My normal body temperature is 96.8°. So I am always cold, unless it is July or early August! None of this heat “therapy” helps alleviate any pain, other than baths… and the effect lasts for no more than 2 hours. Doing dishes warms up my hands temporarily, but doesn’t alleviate pain anywhere other than my hands – momentarily. Ironically, standing to do dishes increases pain in my legs, back, shoulders, and neck. Can’t sit on a stool the way kitchen is configured. I am glad this treatment helped some, but based on my experience I doubt it would be helpful for me. Perhaps half of it is a mental placebo effect? The device looks “medical” or “scientific”? Are the people administering the treatment wearing lab coats? I wonder how long the participants’ pain was alleviated for? Momentarily? An hour or two?

    Wendy

  7. StevefromMA says:

    Sorry you are a member of the chronic pain crew, Wendy. I am trying to find a consultant who will authorize an f(MRI). After all of these years, I’d like to actually see what the inflammation in my brain looks like and where it is specifically. It will also let me send it effortlessly around the world for consult or clinical trial if those arise.

    As for the Avocen, I have no connection with the company but, if you can put up the $2300 up front, the trial is a no-brainer. It might work and change your life and you will get your money back promptly if not. They will take your calls, Steve also, and answer your questions. The treatment is the most benign you can find, putting your hand in a little “roaster” that increases your microcirculation in your hand and then your system. I have tried many devices, unsuccessfully, unfortunately, but they all work for some people. Any company that offers a trial is not a scam, IMO, and realizes that chronic pain is highly individualistic. I will try anything with a trial, am always hopeful.

  8. Rose says:

    All I can say is I have had the Avacen for over one year and use it faithfully twice per day. For me it works very, very well for pain of Fibro, Autoimmune and Sciatica. You must be faithful to at least 20 minutes twice per day which I do “most” days.

    Rose

    • Tim Bossie says:

      That is great to hear about Avacen working and helping you with the pain of Fibro. And… you are so right in saying that you must be faithful to using it.

  9. Denise Bault says:

    The research I’ve done…and I’ve done a lot…says that most folks develop fibromyalgia after one of and/or a combination of: accidents, surgeries, and way too much stress. Not surprised you developed it after surgery. Glad the new meds are working for you!

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