Neuros Medical Inc.

Neuros Medical Inc. manufactures the Altius Direct Electrical Nerve Stimulation System, an FDA-approved implantable neuromodulation device designed for chronic post-amputation pain management in adult lower limb amputees. The Altius system provides on-demand pain relief for phantom limb pain and residual limb pain through patient-controlled electrical stimulation delivered directly to affected nerves via an implantable pulse generator and wireless controller. The system enables patients to initiate therapy when needed without scheduled treatments. Clinical evidence from the QUEST study (180 patients) demonstrated significant therapeutic outcomes: 44% improvement in walking ability, 51% improvement in sleep quality, and 45% improvement in overall quality of life. Patients achieved approximately 30% pain reduction within 30 minutes of therapy initiation and approximately 50% pain reduction at 120 minutes. The device is indicated as an aid in managing chronic intractable phantom and residual lower limb post-amputation pain. FDA approval reflects successful demonstration of safety and effectiveness, though the agency imposed a post-market condition requiring human factors engineering and usability validation testing per FDA's 2016 guidance. The company markets directly to eligible amputees and coordinates with healthcare providers for surgical implantation and ongoing management. Contraindications include patient inability to operate the system and unsuitability for implant surgery. Key safety considerations include incompatibility with diathermy, potential electromagnetic interference, cardiac device interactions, contraindication for MRI/NMRI, and increased adverse event frequency in diabetic patients.