San Diego, California based AVACEN Medical introduced its FDA cleared noninvasive AVACEN 100 muscle relaxation medical device at the PAINWeek 2015 conference that ran from September 8 to 12 at The Cosmopolitan in Las Vegas, Nevada. The largest annual US pain meeting for frontline practitioners with an interest in pain management, over 2100 physicians, physician assistants, nurse practitioners, nurses, pharmacists, hospitalists, dentists, psychologists, and social workers were expected to attend this year.
The AVACEN 100 device is a futuristic-looking muscle-relaxing “mystery machine,” about the size of a bread box. According to AVACEN Medical, if you stick your hand inside the device for 20 minutes some really great things may happen, such as dissipation of pain, along with the foggy shroud that often accompanies it and joints more freely movable. Addtionally they say that for many, eyelids will become heavy, stress fades, and some users will actually fall asleep.
Over the last half-decade, AVACEN Medical has applied for and been awarded multiple U.S. and International patents for their novel apparatus and the methods that support its innovative medical process called the AVACEN Treatment Method. The company says its AVACEN 100 is the only OTC medical device currently on the market capable of providing a noninvasive rapid whole body treatment using a single point of contact for muscular relaxation and temporary relief of joint pain associated with arthritis.
While muscle relaxant drugs are widely prescribed, AVACEN Medical notes that evidence supporting effectiveness of available muscle relaxants is sparse, with most of these medicines causing extended sedation and some posing increased risk of serious side-effects, such as liver toxicity and addiction.
With over 3,000 built-in firmware instructions controlling the experience, the microprocessor controlled AVACEN 100 is pitched as pain therapy alternative for people who need or prefer cost effective, easy to use, drug-free way to address temporary relief of pain that may be associated with a variety of chronic and acute medical conditions such as arthritis. Besides avoiding the potential detrimental effects of gastric pain and development of gastric ulcers possible damage to the heart or liver, or even addiction variously associated with some pain medications, additional reasons for opting for non-drug pain therapy may include values or philosophical orientations, insufficient response to pain medications, or pregnancy, nursing, or pre-pregnancy.
Features of the AVACEN 100 include 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. A Sanitary mitt increases device life and function, and allows a single machine to be sanitarily used by a family or group of users.
According to AVACEN Medical CEO Thomas Muehlbauer, “The AVACEN 100 uses the AVACEN Treatment Method to address numerous existing worldwide consumer and commercial markets. By non-invasively infusing heat into the circulatory system under negative pressure, it increases microvascular circulation, reduces blood viscosity and enhances deep tissue nutrition. The result rapid muscle relaxation throughout the body. Think of it as a sauna from the inside out but without the sweating, overheating risks, contraindications and inconvenience.”
Developed to support the AVACEN Treatment Method (ATM), the AVACEN 100 is a FDA cleared class II OTC medical device, and claimed to be the world’s only noninvasive medical device that supports systemic patient self-treatment from a single convenient treatment point (their palm) in the privacy of their own home.
The AVACEN 100 is pending U.S. FDA approval for widespread pain related to fibromyalgia and currently cleared for the temporary relief of joint pain associated with arthritis; muscle spasms; minor strains and sprains; and muscular relaxation.
Easy-to-Use And Over-The-Counter (OTC)
The therapy procedure is simplicity itself. Users put their hand inside the AVACEN 100 vacuum chamber and rest it on a heated pad for 10 to 30 minutes. AVACEN Medical says more than 300,000 treatments have been completed without adverse events. Easy to understand instructions are presented on the device’s Display Screen, although if you use the preset AVACEN 100 defaults, only a single button press is required.
The AVACEN 100 is a patented and FDA cleared Class II, Over The Counter (OTC) medical device that uses cutting edge technology developed by AVACEN Medical that incorporates heat therapy and negative atmospheric pressure. The AVACEN Treatment Method (ATM) a noninvasive pain management technology platform uses a microprocessor controlled chamber to surround the hand with a slight negative pressure, while adding heat to the palm to stimulate local circulation and infuse heat into a unique vascular network, located in the palm of the hand. The company says that raising blood temperature at this single point of treatment (the palm) increases blood temperature naturally throughout the circulatory system, which can benefit the entire body.
Likely candidates to benefit from the ATM are persons needing temporary relief of minor muscle and joint pain and stiffness; temporary relief of joint pain associated with arthritis, muscle spasms, minor strains and sprains; and general muscle relaxation.
AVACEN Medical cites an AVACEN Treatment Method Study
Conducted by The Department of Veterans Affairs and The University of California, San Diego that found a greater than 40 percent reduction in widespread muscle pain, zero negative side effects and a statistically significant reduction in “Mean Arterial Pressure” with use of the AVACEN 100 device.
The AVACEN 100 does not require a medical prescription, and is not covered by medical insurance at this time. It is offered with a 60-day money back return policy, a 12-month 100% replacement warranty, and comes with a two- year supply of disposable sanitary mitts and a power supply that operates on 100-240V for international travel. Terms are available through PayPal Credit. For details and pricing see:
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PAINWeek 2015 conference