Neuros Medical, Inc. announced today acceptance for publication of the 3-month results from the landmark QUEST Study demonstrating treatment with the Altius® Direct Electrical Nerve Stimulation System results in immediate and lasting pain reduction, decreased opioid use, and improved quality of life in patients suffering with chronic post-amputation pain. The study, which enrolled 180 patients with a unilateral lower limb amputation across 35 sites in the U.S., is the largest prospective, double-blinded, randomized study ever conducted for treatment of chronic post-amputation pain.
Summary of 3-Month Results
Primary efficacy and safety endpoints were met, demonstrating superiority of treatment over active-sham control. Patients receiving Altius® treatment also experienced the following benefits compared to control patients:
- Highly statistically significant reduction in acute pain at 30 minutes after initiating treatment that increased significantly at 120 minutes.
- 32% reduction in daily average pain scores, indicating a lasting effect of the treatment on their pain profiles.
- 56% decrease in opioid use.
- 39% improvement in quality of life.
The study authors concluded that treatment with the Altius® System represents a significant advancement for lower limb amputees suffering with chronic post-amputation pain where there is currently a lack of effective treatment options.
Highlights from the 3-month results were presented at the 16th World Congress of the International Neuromodulation Society earlier this month by 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 have never seen a study of this magnitude and rigor in this patient population,” said Dr. Kapural. “The data demonstrated clear and lasting benefit of treatment for pain reduction and functional outcomes at three months, creating great optimism for the long-term study results. These findings represent a significant advancement for an at-risk and underserved patient population in desperate need of reliable and effective treatment.”
“On behalf of the entire Neuros organization, I would like to thank the principal study site investigators and their teams for outstanding clinical execution and patient centric care,” said David Veino, President & CEO, Neuros Medical. “The QUEST primary endpoint data demonstrates to the amputee community that relieving pain and restoring life is more than just hope, it’s now a reality. We look forward to the longer term 12-month results being published later this year.”
About the QUEST Study
The QUEST Study is a multicenter, double-blinded, randomized, active-sham controlled pivotal study designed to assess the efficacy and safety of the Altius® Direct Electrical Nerve Stimulation System in patients with chronic post-amputation lower limb pain. The Investigational Device Exemption (IDE) study enrolled 180 patients with a unilateral lower limb amputation across 35 sites in the U.S. Patients were randomized 1:1 to active treatment or active sham groups with a single arm cross-over to active treatment at 3 months and follow-up to 12 months. The primary efficacy endpoint was at least a 50% pain reduction in at least 50% of treatment sessions 30 minutes after initiating treatment. Secondary efficacy endpoints included at least a 50% pain reduction in at least 50% of treatment sessions after 120 minutes, change in opioid medication use, and improvement in quality of life. The primary safety endpoint was incidence of all serious adverse events.
About the Altius® Direct Electrical Nerve Stimulation System
The Altius® System is a patient-controlled, on demand system that uses Neuros’ patented technology to address the underlying cause of post-amputation pain by inhibiting pain signal transmission from the damaged peripheral nerves near the site of amputation to the central nervous system. The system consists of a nerve cuff electrode placed around an affected nerve and an implantable pulse generator (IPG). Patients initiate an on-demand 30-minute treatment session as needed for targeted pain relief.
Caution – Investigational Device. Limited by Federal (or United States) law to investigational use.