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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…

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Transmural Systems Receives the US FDA 510(k) Clearance for TELLTALE to Prevent Coronary Obstruction During TAVR

Shots: The US FDA has granted 510(k) clearance to TELLTALE for the prevention of coronary obstruction in pts undergoing Transcatheter Aortic Valve Replacement (TAVR) for both native aortic stenosis & bioprosthetic valve failure FDA cleared TELLTALE following a pivotal study demonstrating the device’s safety & effectiveness for leaflet modification in pts at risk of coronary…

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