Neuros Medical announced publication of the 12-month results from the QUEST study of its Altius Direct Electrical Nerve Stimulation System. The results demonstrated that the treatment resulted in clinically significant and lasting pain reduction, decreased opioid use, and improved quality of life in amputees with chronic post-amputation pain.
The study enrolled 180 patients with unilateral lower-limb amputations across 35 sites in the United States and is the largest prospective, double-blinded, randomized study for treatment of chronic post-amputation pain.
Patients receiving treatment with the Altius System reported a 30-50 percent reduction in pain 30 minutes and 120 minutes after initiating therapy, respectively, and continued reduction in daily pain levels through 12 months.
They also reported a 50 percent reduction in days with pain, and 81 percent of patients taking opioids decreased or eliminated opioid use.
“Chronic post-amputation pain is a debilitating condition affecting a large majority of lower-limb amputees and persists over long periods of their lifetime,” said John Eidt, MD, chief of vascular surgery at Baylor Scott and White Heart and Vascular Hospital, and QUEST investigator. “An ideal treatment needs to be on-demand, patient-controlled, and provide lasting reduction in pain without the risk of addiction associated with opioids. QUEST demonstrated a clinically significant reduction in pain sustained through 12 months, allowing patients to reduce or eliminate the use of opioids. The Altius System has the potential to be the gold standard for treatment of chronic post-amputation pain.”
Neuros plans to begin commercialization of the Altius System this year.
The open-access study, “Long-term treatment of chronic postamputation pain with bioelectric nerve block: Twelve-month results of the randomized, double-blinded, cross-over QUEST study,” was published in Neuromodulation: Technology at the Neural Interface.
