Neuros Medical, Willoughby, Ohio, announced that it has received an Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) allowing it to commence a clinical trial to evaluate the company’s patented Altius™ System High Frequency Nerve Block technology for the management of intractable limb pain of individuals with amputations.
The prospective, randomized, controlled clinical trial will consist of 130 patients at 15 institutions in the United States to evaluate the safety and efficacy of Neuros Medical’s Altius System. Neuros recently announced the results of its long-term pilot study, which reported significant pain reduction. In addition, more than half of the subjects discontinued their pain medication use during the study.
“We look forward to executing the next steps in the pivotal study process with the eventual goal of receiving approval to market the Altius System to provide long-term pain relief to those suffering from chronic amputation pain,” said Jon J. Snyder, president and CEO of Neuros Medical.