Going Gaga for EU approved fibromyalgia device

Avacen Medical has announced that its medical device designed to help treat pain associated with fibromyalgia has received approval for EU markets.

The company’s Avacen 100 is a class II medical device that non-invasively infuses heat into the circulatory system to create muscular relaxation while increasing microcirculation throughout the body. The company claims that the device offers widespread pain relief.

Fibromyalgia was recently thrust into the spotlight by Lady Gaga, who revealed she has been living with the disorder. It is a long-term condition that causes pain all over the body, thought to be caused by abnormal levels of chemicals in the brain which change the way the central nervous system processes pain messages, according to the NHS.

Class II medical devices are usually submitted to the FDA for pre-market notification, otherwise known as a 510(k). Class II devices can be approved on the grounds that they work in an equivalent way to devices already approved for market. The Avacen 100’s CE mark was based on a phase 2 study of 22 with fibromyalgia over 28 days. The study showed positive results for all participants and highlighted a 40% reduction in widespread pain index overall.

Avacen Medical CEO Thomas Muehlbauer said the Avacen 100 is “the only 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.”

About the device, Amanda from Essex who suffers from fibromyalgia, said: “I had difficulty driving, getting dressed and washing my hair, experiencing no sleep at all, tremendous pain, with every movement sending my body in painful spasm… I cannot recommend the Avacen 100 enough, how this has and is helping me… the physio will be amazed with my progress. "