Emboline Receives US FDA 510(k) Clearance for Emboliner Embolic Protection System

Shots: FDA has granted 510(k) clearance to Emboliner Embolic Protection System for use as an embolic protection device to capture & remove embolic material during transcatheter aortic valve replacement (TAVR), with phased commercial launch to begin later this year Clearance was backed by extensive clinical data, incl. the PROTECT H2H IDE study assessing Emboliner vs. Sentinel Cerebral Protection System, meeting its primary safety & clinical performance endpoints, showing Emboliner captured significantly more debris during TAVR Emboliner provides comprehensive cerebral & systemic embolic protection during TAVR by capturing & removing debris before it reaches vital organs. Its circumferential dual-layer filter protects cerebral & systemic circulation while allowing the TAVR delivery system through its central lumen Ref: PRnewswire  | Image: Emboline  |  Press Release PharmaShots, your go-to media platform for customized news ranging across multiple indications. For more information, connect with us at connect@pharmashots.com The post Emboline Receives US FDA 510(k) Clearance for Emboliner Embolic Protection System appeared first on PharmaShots.