Dec 14 2015
StimRelieve LLC, a privately held medical device company, today announced that it has received FDA Investigational Device Exemption (IDE) approval to launch a clinical trial of the world’s smallest percutaneously implantable device for the treatment of chronic migraine refractory to more conservative therapies such as NSAIDs, migraine-specific drugs, or combination drug therapy. The StimRelieve Halo Migraine System uses wirelessly-powered neurostimulators leveraging nanotechnology for the treatment of chronic migraines.
“To date, treatments for chronic migraines have had limited and inconsistent results,” said Konstantin Slavin, MD, Professor of Neurosurgery at the University of Illinois, Chicago. “Chronic migraine headache pain is a crippling condition, disabling millions of Americans every year. If determined safe and effective, StimRelieve’s wireless neuromodulation device offers a promising option for alleviating and controlling this type of condition so that those living with this pain can better function and go on with their lives.”
It is estimated that 45 million Americans suffer from chronic migraines each year, resulting in 20 million physician visits. The economic impacts of chronic migraines are enormous due to work lost and lower productivity. Existing conventional medical treatments are limited and have mixed results. While peripheral nerve stimulation has emerged as a potential method for treating chronic migraines, the traditional application of this methodology has presented significant barriers and negative side effects.
This clinical trial will assess the safety and effectiveness of occipital and supraorbital nerve stimulation using the StimRelieve Halo Migraine System for the treatment of chronic migraines. The StimRelieve Halo Migraine System is based on wireless neuromodulation technology. It is among the world’s smallest devices – 95 percent smaller than other implanted options – and is implantable with a standard gauge needle, thus eliminating the need for extensive surgery to the face, head and neck.
Unlike other devices, there is no implanted battery pack placed in the patient. Instead, a discreetly-worn external transmitter worn on the ear provides energy and therapy to the implanted device. The goal of the study is to achieve a 30 percent reduction in headaches with no increase in medication at three months as compared to the control group that will have no active treatment during the same period.
“We are delighted to be moving forward with this study to demonstrate the potential of our product platform to address a wide variety of chronic issues with minimally-invasive neuromodulation treatments,” said Laura Tyler Perryman, StimRelieve chairman and president. “If this study demonstrates safety and effectiveness, StimRelieve can help millions of people in the U.S. who are suffering from chronic migraines, without the need for extensive surgery or bulky implants in their chest.”
StimRelieve products are not approved for sale or commercial distribution, and are limited to investigational use only. For more information about the StimRelieve clinical trials for the treatment of medically intractable headache syndromes, please visit www.clinicaltrials.gov.
Source: http://www.stimrelieve.com/