Health Canada Approves Avacen’s Non-Drug Treatment Device for Fibromyalgia Pain

Health Canada Approves Avacen’s Non-Drug Treatment Device for Fibromyalgia Pain

Avacen Medical says its Avacen 100 Class-II medical pain treatment product has received a medical device license from Health Canada to treat fibromyalgia. The San Diego-based biotech firm’s marquee product uses a non-invasive technique for safely infusing heat into the body’s circulatory system.

Avacen says its device relaxes muscles while increasing microcirculation throughout the body, and that unlike other local pain relief medical devices, the Avacen 100’s proprietary action mechanism provides widespread, systemic pain relief.

CEO Thomas Muehlbauer described the device in a press release as “the only OTC [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 the ideal drug-free and safe alternative for relief of muscle and joint pain.”

The device is not for sale in the United States, Canada, Europe or India for the treatment of any non-cleared or non-approved indication.

Canadian federal and provincial healthcare officials are worried about the growing number of opioid drug-related deaths, partly from street fentanyl but also from the abuse of legal prescription painkillers.

“The most exciting aspect of this approval is that the Canadian market has shown high demand and acceptance for innovative new alternatives to pharmaceuticals for treating pain.” said Muehlbauer, whose company already has approval in the European Union to market the Avacen 100 throughout the EU’s 28 member countries. Many of them have rejected prescription drugs — including some available in the United States — for treating fibromyalgia pain.

Besides fibromyalgia’s devastating impact on quality of life, it imposes a huge economic burden on both healthcare providers and people battling the disease.

Avacen 100. Photo credit: Avacen Medical

Avacen cited a recent Canadian study published in the journal BMC Musculoskeletal Disorders showing that fibromyalgia costs patients an average C$3,804 per year. The study, Fibromyalgia-related costs and loss of productivity: a substantial societal burden,” found that besides prescribed medications, two-thirds of study participants also purchased over-the-counter pain medication, and more than half bought natural health products — both included in out-of-pocket costs.

The Avacen 100 device sells for US$2,595, with an estimated operating lifetime of five to 10 years. It features a patient compliance enhancing game mode, a custom hand sensor, adjustable heat and time controls, an easy-to-read LCD screen and device usage monitor.

The procedure is quite simple; users put their hand inside the Avacen 100 vacuum chamber and rest it on a heated pad for 10 to 30 minutes. Avacen says more than 300,000 treatments have been completed without adverse events.

 

4 comments

  1. Jackie says:

    This would help me… I get chronic long lasting constant base of my skull pain that causes me extreme lethargic pain.. Down my neck..over my skull into my face.. I can’t take the pain anymore.. I wont take narcotics….

  2. Teresa Madore says:

    Equipment like this is so highly priced that that those of us whoare on Disability due to Fibro & Arthritis can not afford a machine like this…..opiod pain meds are covered by our Soscial Services drug plan ODB….soyou see it’s a two tear system for the rich or those not disabled enough to have to give up their jobs and may have benefits to cover. Its a great idea for the rich …..

  3. Catherine Vigna says:

    ” … sells for US $2,595, with an estimated operating lifetime of five to 10 years.” Holy crap, most people who suffer from Fibromyalgia live on very small disability incomes – there is absolutely no way we could ever afford this! And with that kind of operating lifetime, we’d have to start all over again to save up to purchase another – and you can bet the cost would be astronomical by then! Seriously? Do they buy it back if it doesn’t work for the person suffering? Or are we supposed to just write-off that kind of expense that we couldn’t afford anyway?

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