Neuros Medical, Inc., a medical device company announced it has received an Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) allowing it to commence a pivotal clinical trial to evaluate the Company’s patented Altius™ System High Frequency Nerve Block technology for the management of intractable limb pain of amputees.
The prospective, randomized, controlled pivotal clinical trial will consist of 130 patients at 15 institutions in the U.S. to evaluate the safety and efficacy of Neuros Medical’s Altius System. When completed, the results will support a PreMarket Approval Application to FDA in order to market the device. Neuros recently announced the results of their 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.
Dr. Zi-Ping Fang, Chief Scientific Officer of Neuros Medical stated, “Receiving the IDE approval from the FDA to move forward with our pivotal study is an important milestone in the development of our technology.” Jon J. Snyder, President and CEO of Neuros Medical, added, “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.”