Neuros Medical Receives Investigational Device Exemption (IDE) Approval for Implantable Device
Neuros Medical Inc. officials announced it has received an Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration for their implantable generator. The device, named Altius, delivers patented high frequency Electrical Nerve Block technology for patients suffering from chronic pain.
Neuros recently announced the results of their long-term pilot study, which focused on patients afflicted with chronic amputation pain. Seven out of 9 study subjects, utilizing an external generator, reported significant pain reduction (defined as 50% or greater) observed for up to 12 months of evaluation. The study demonstrated no safety issues over the treatment period. Study subjects reported an average pain score reduction of 6 to 1 (an 83% pain reduction) based on a 0 to 10 Numerical Rating Scale. In addition, more than half of the subjects discontinued their narcotic pain medication use during the study. Subjects enrolled in the long-term pilot study will now be able to utilize the implantable generator.
Jon J. Snyder, president and CEO of Neuros Medical, states, “We are extremely pleased with the IDE approval and look forward to converting the pilot study participants to the Altius implantable device, continuing to provide long-term pain relief to those suffering from chronic amputation pain.”