Neuros Medical has announced that it has received an investigational device exemption (IDE) approval from the US Food and Drug Administration for their implantable generator. The Altius device 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 nine study subjects, utilising 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 six to one (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 utilise the implantable generator.
Jon J Snyder, president and CEO of Neuros Medical, said, “We look forward to converting the pilot study participants to the Altius implantable device and continuing to provide long-term pain relief to those suffering from chronic amputation pain.”