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).