Mississauga, Ontario-based Epineuron designed its handheld, intraoperative Evala electrical nerve stimulation device to provide surgeons with a rapid and accurate solution for nerve identification and functional evaluation of different nerve sizes, both large and small.
Epineuron said FDA clearance marks a significant expansion of its portfolio. It also expands the commercial footprint of its proprietary bioelectronic platform for peripheral nerve care.
Dr. Jana Dengler, a peripheral nerve surgeon at Sunnybrook Health Sciences Centre in Toronto, served as an early user of Evala. Dengler said the technology enables the evaluation of nerves in scarred revision surgeries, nerve transfers, under extended tourniquet time and in conjunction with PeriPulse, Epineuron’s device that sends electrical impulses directly to the damaged nerve during or shortly after surgery.