Neuros Medical, Willoughby Hills, Ohio, received Breakthrough Device designation from the US Food and Drug Administration (FDA) for the use of its nerve block system, Altius, as an aid in the management of chronic intractable pain of the lower limb in adults with amputations.
The FDA Breakthrough Device program is intended to help patients and healthcare providers receive timely access to medical devices that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions. Chronic post-amputation pain is considered a significant unmet medical need due to existing treatment options being limited, and treatment consists primarily of opioids and gabapentinoids. Chronic post-amputation pain is estimated to affect 30-80 percent of patients who undergo a major limb amputation.
Neuros Medical anticipates completion of enrollment in its study assessing the safety and effectiveness of the Altius system by this fall. The study is a 180-patient, double-blinded, active, sham-controlled randomized clinical trial that is being conducted under an Investigational Device Exemption.