Neuros Medical today announced that it has received FDA clearance for its Altius direct electrical nerve stimulation system.

The FDA approved Altius as an aid in the treatment of chronic, intractable phantom and residual lower limb pain following amputation in adult amputees. Approval was based on results from the QUEST trial, which met all primary efficacy and safety endpoints.

Aliso Viejo, Calif.-based Neuros said Altius demonstrated treatment superiority over an active sham treatment in the QUEST trial. Patients who received Altius reported statistically significant and sustained pain relief. They also reported lower opioid use and improved quality of life.

Dr. Leonardo Kapural of the Carolinas Pain Institute was the national principal investigator for QUEST. In a press release, Kapural said Altius offers a solution supported by the first rigorous, randomized controlled trial in this patient population.

Neuros plans to begin commercializing the Altius system later this year.

“The FDA approval of the Altius System 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, patient-controlled device without the risk of addiction associated with opioids,” said David VeinoPresident and CEO of Neuros Medical. “We are grateful to the researchers and subjects of the QUEST study who have overcome many challenges, including COVID, to bring the Altius System to the amputee community.”