The Stentrode is the world's only endovascular brain-computer interface, implanted via a minimally invasive catheter procedure through the jugular vein into the superior sagittal sinus — a large blood vessel running along the top of the brain. No open brain surgery is required. Once deployed, the self-expanding nitinol stent-electrode array conforms to the vessel wall adjacent to the motor cortex, recording local field potentials and action potentials through the vessel wall. Signals are transmitted subcutaneously to a chest-mounted Investigational Transmitter Device (ITD). The system received FDA Breakthrough Device Designation in 2020 and has been implanted in over 10 patients across the US and Australia.
FDA Breakthrough Device Designation provides more interactive communication with FDA during development and a priority review pathway. The device is still under investigation and not yet approved for commercial sale.
FDA Device Regulatory Guidance ↗