Neuros Medical Inc., a Cleveland, Ohio-based neuromodulation medical device company, has received an Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration for its implantable generator.
The device, named Altius, delivers patented high-frequency nerve-blocking 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, using an external generator, reported significant pain reduction (defined as 50 percent or greater) observed for up to 12 months of evaluation. The study demonstrated no safety issues during the treatment period. Study subjects reported an average pain score reduction of 6 to 1 (an 83 percnet pain reduction) based on a 0 to 10 rating scale. In addition, more than half of the subjects discontinued their narcotic pain medication use during the study, the company reported. Subjects enrolled in the long-term pilot study now will be able to use the implantable generator.
Jon J. Snyder, president and CEO of Neuros Medical, said, “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.”
The company’s patented platform technology, called Electrical Nerve Block, is focused on the elimination of chronic pain in a variety of conditions including amputation pain, post-surgical pain, migraine and trigeminal neuralgia (a nerve disorder that causes a stabbing or electric-shock-like pain in parts of the face).