Neuros Medical received approval from the United States Food and Drug Administration (FDA) for its Altius Direct Electrical Nerve Stimulation System. The Altius System is indicated as an aid in the management of chronic intractable phantom and residual lower-limb pain in adults with amputations.
The approval was based on the results of a study called “High-FreQUEncy Nerve Block for PoST-Amputation Pain” (QUEST), in which all primary efficacy and safety endpoints were met, and it demonstrated improved results 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.
“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, Neuros Medical. “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.”
Neuros plans to begin commercialization later this year.
