SANTA CRUZ, Calif., Sept. 9, 2026 /PRNewswire/ — Emboline, Inc., a medical technology company developing next-generation embolic protection technology, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the Emboliner® Embolic Protection System for use during transcatheter heart procedures. The Emboliner is indicated for use as an embolic protection device to capture and remove embolic material during transcatheter aortic valve replacement (TAVR).
The Emboliner system is designed to provide comprehensive cerebral and systemic embolic protection during TAVR by capturing and removing embolic debris before it can travel to the brain, kidneys and other vital organs. Unlike embolic protection devices that cover selected cerebral vessels, the Emboliner uses a circumferential dual-layer filter to protect the cerebral and systemic circulation while allowing the TAVR delivery system to pass through its central working lumen.