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…
