Neuros Medical Receives FDA Approval for the Altius® Direct Electrical Nerve Stimulation System
Neuros Medical has received approval from the United States Food and Drug Administration (FDA) for its Altius® Direct Electrical Nerve Stimulation System, indicated for the management of chronic, intractable phantom and residual lower limb post-amputation pain in adult amputees. The Altius® System is a patient-controlled, on-demand system that uses Neuros’ patented technology to address the underlying cause of post-amputation pain by inhibiting pain signal transmission from the damaged peripheral nerves near the amputation site to the central nervous system. The system includes a nerve cuff electrode placed around the affected nerve and an implantable pulse generator (IPG). Patients can initiate a 30-minute treatment session as needed for targeted pain relief.
The approval of the Altius® System was based on the results of the QUEST study, which met all primary efficacy and safety endpoints, demonstrating the treatment’s superiority over active-sham control. Patients receiving Altius® treatment reported statistically significant and lasting reductions in pain, decreased opioid use, and improvements in quality of life.
Physicians and patients now have a clinically proven treatment that addresses the underlying cause of post-amputation pain using an innovative, on-demand, patient-controlled device without the risk of addiction associated with opioids,” said David Veino, President & CEO of Neuros Medical. The company plans to begin commercialization of the Altius® System later this year.
