US-based medical device company Neuros Medical has obtained an investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) for its Altius, an implantable generator that delivers high frequency Electrical Nerve Block technology for patients suffering from chronic pain.
Recently, the company had announced results from its long-term pilot study done on patients suffering from chronic amputation pain.
A total of nine subjects have participated in the pilot study and seven subjects who used an external generator reported significant pain reduction observed for around 12 months of evaluation.
Based on a 0 to 10 numerical rating scale, the study subjects reported an average pain score reduction of 6 to 1 (an 83% pain reduction), and during the treatment period the study has not shown any safety issues.
More than half of the subjects discontinued the narcotic pain medication use during the study.
Neuros Medical president and CEO Jon J. Snyder 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."