Neuros Medical has received a Breakthrough Device designation from the FDA for its High-Frequency Nerve Block system for management of chronic pain of the lower limbs in adult amputees.

The system consists of an electrode and an implantable pulse generator that deliver a high-frequency electrical signal to the peripheral nervous system to block the pain signal, providing an alternative to opioids and gabapentinoids for postamputation pain.

The company plans to complete enrollment in a 180-participant clinical trial of the device this fall.