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. The self-expanding nitinol stent embedded with thin-film platinum-iridium electrodes records local field potentials and high-gamma activity through the vessel wall. Signals are transmitted to a subcutaneous chest-mounted transmitter. Median deployment time is 20 minutes. The COMMAND study demonstrated 100% accurate deployment with zero neurologic safety events across 6 patients over 12 months. Patients have demonstrated control of mouse cursors, Apple Vision Pro, Amazon Alexa, and iPads.
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 ↗