Neuros Medical, announced today that it has received approval from the United States Food and Drug Administration (FDA) for its Altius Direct Electrical Nerve Stimulation System.
The Altius Direct Electrical Nerve Stimulation System is indicated as an aid in the management of chronic intractable phantom and residual lower limb post-amputation pain in adult amputees.
The labeling for the Altius System was based on the results of the QUEST study in which all primary efficacy and safety endpoints were met, demonstrating superiority of treatment 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.
“Approval of the Altius System represents a significant advancement for lower limb amputees who for years have suffered from chronic debilitating pain with largely ineffective treatment options,” said Dr. Leonardo Kapural MD, PhD, Professor of Anesthesiology at Florida Atlantic University and Partner at Carolinas Pain Institute and the QUEST study National Principal Investigator. “We finally have a solution proven to reduce pain and improve quality of life, and one backed by the first rigorous, randomized controlled trial conducted in this patient population.”
“The approval of the Altius System by the FDA is a significant milestone in the treatment of post-amputation pain,” said David Veino, President & CEO, 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.”
