Neuros Medical announced it received FDA approval for its Altius direct electrical nerve stimulation system.
The FDA cleared Altius as an aid in the management of chronic intractable phantom and residual lower limb post-amputation pain in adult amputees. Labeling came on the back of results from the QUEST study, which met all primary efficacy and safety endpoints.
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Aliso Viejo, California-based Neuros said Altius demonstrated superiority of treatment over active-sham control in the QUEST study. Patients receiving Altius reported statistically significant and lasting reductions in pain. They also reported decreased opioid use and improvements in quality of life.
Dr. Leonardo Kapural of Carolinas Pain Institute served as national principal investigator for QUEST. In a news release, Kapural said Altius provides a solution backed by the first rigorous, randomized controlled trial of this patient population.
Neuros plans to begin commercialization of the Altius system later this year.
“The approval of the Altius system by the FDA is a significant milestone in the treatment of post-amputation pain. 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, 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.”
