FDA Approves Breakthrough Device: Altius System to Tackle Chronic Amputation Pain

The FDA has approved the Altius® System, an innovative device for managing chronic pain in lower limb amputees. Utilizing direct electrical nerve stimulation, the device proved effective in reducing pain and opioid use in the QUEST study. The approval represents a paradigm shift in pain management and reduces opioid use.

Neuros Medical announced that its Altius® Direct Electrical Nerve Stimulation System received US Food and Drug Administration (FDA) approval for the treatment of chronic intractable post-amputation pain in adult lower limb amputees. This approval marks a significant advancement in pain management for amputees, offering a non-opioid, patient-controlled solution that has demonstrated superior efficacy in clinical trials.

"This approval represents a significant advancement for lower limb amputees who for years have suffered from chronic debilitating pain with largely ineffective treatment options. 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," said Dr. Leonardo Kapural, a Professor of Anesthesiology at Florida Atlantic University.

Breakthrough in Pain Management

The FDA's decision was based on the results of the QUEST study, a rigorous, randomized controlled trial that demonstrated the Altius® System's superiority over active-sham control. The study met all primary efficacy and safety endpoints, with patients reporting significant and lasting reductions in pain, decreased opioid use, and improved quality of life.

The Altius® System is designed to manage chronic intractable phantom and residual lower limb post-amputation pain in adult amputees, addressing a long-standing challenge in pain management for millions of patients. This innovative device operates by directly stimulating nerves with electrical impulses, offering a non-opioid alternative to those grappling with intense, long-term discomfort.

David Veino, President & CEO of Neuros Medical, also emphasized the system’s significance. "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." 

How the Altius® System Works

The Altius® System introduces a transformative approach to treating post-amputation pain by addressing its underlying cause with a patient-controlled, on-demand solution. Featuring a nerve cuff electrode and an implantable pulse generator, the system enables amputees to initiate 30-minute treatment sessions that provide targeted relief. This innovative method blocks pain signal transmission to the brain and offers a significant alternative to opioid-based therapies, eliminating the risk of addiction.

Addressing a Widespread Challenge 

The approval of the Altius® System opens new possibilities for millions of amputees suffering from chronic pain. By offering a non-pharmacological approach to pain management, it has the potential to significantly improve the quality of life for this patient group while reducing reliance on opioid medications. Neuros Medical plans to begin commercialization of the Altius® System later this year, marking the start of a new era in post-amputation pain management.

About Author: Tracy Mokwe

With over 3 years of experience as a medical laboratory scientist and writer, I am passionate about translating complex scientific information into clear and accessible content. My expertise lies in medical sciences, laboratory science and research, digital health, AI, and cybersecurity in healthcare.