Neuros Medical has received Breakthrough Device designation from the US Food and Drug Administration (FDA) for the use of its novel, high-frequency nerve block system, Altius, as an aid in the management of chronic intractable pain of the lower limb in adult amputees. The FDA Breakthrough Device programme 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.
In the USA, there are nearly two million lower-limb amputees, according to a company press release, with 160,000 new amputations occurring annually. Chronic post-amputation pain is a “significant unmet medical need” due to existing treatment options being limited, and consisting primarily of opioids and gabapentinoids. Chronic post-amputation pain is also estimated to affect approximately 30–80% of patients who undergo a major limb amputation, the release adds.
Neuros Medical anticipates completion of enrolment in its pivotal QUEST (High-frequency nerve block for post-amputation pain) study by autumn 2021. QUEST is a 180-patient, double-blinded, active, sham-controlled randomised clinical trial that is being conducted under an Investigational Device Exemption (IDE). It is designed to assess the safety and effectiveness of the company’s Altius system to treat chronic intractable post-amputation pain.
“The Altius System—as a designated Breakthrough Device—is the result of outstanding multidisciplinary teamwork, and we look forward to completion of QUEST enrolment this fall as another key milestone in our effort to develop this important therapy option for patients who suffer from chronic post-amputation pain,” said William Patterson, chief technology officer at Neuros Medical.