FDA OKs Neuros Medical’s Altius Neurostim Device

Neuros Medical has gained approval from the U.S. Food and Drug Administration (FDA) for its Altius direct electrical nerve stimulation system.
 
Altius helps with management of chronic, intractable phantom and residual lower limb post-amputation pain in adult amputees. Its technology inhibits transmission of pain signals from damaged peripheral nerves near the amputation site to the central nervous system.
 
The device aims to respond to the unmet need of treatment options for the about 185,000 U.S. phantom and residual limb pain patients, which are limited to primarily opioids and gabapentinoids.
 
The system is comprised of a nerve cuff electrode place around the affected nerve and an implantable pulse generator (IPG). The therapy is a patient-initiated, on demand, 30-minute treatment session as needed for targeted pain relief.
 
Altius earned FDA breakthrough status in 2021 and is the first device with this designation to earn FDA approval this year. Neuros expects to begin commercializing Altius later this year.
 
“The approval of the Altius System by the FDA is a significant milestone in the treatment of post-amputation pain,” said David Veino, president and CEO of Neuros Medical. “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. We are grateful to the QUEST study investigators and study subjects who persevered through many challenges, including COVID, to bring the Altius System to the amputee community.”