mboline has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its Emboliner embolic protection system, intended for use in transcatheter aortic valve replacement (TAVR) and other heart procedures.
The device is indicated to capture and remove embolic material during TAVR, providing protection for both cerebral and systemic circulation.
It employs a circumferential dual-layer filter that covers the cerebral and systemic arteries, aiming to intercept and extract debris generated during the TAVR procedure before it reaches critical organs such as the brain and kidneys.