FDA grants 510(k) clearance to Emboliner system for TAVR procedures

Emboline has secured 510(k) clearance from the FDA for its Emboliner embolic protection system, intended for TAVR and other heart procedures. The FDA's decision follows a clinical assessment of the Emboliner, including the PROTECT H2H IDE study. The system uses a circumferential dual-layer filter to intercept and extract debris during the TAVR procedure. Credit: NMK-Studio / Shutterstock.com. Emboline 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…

Source: Medical Device Network