SILVER SPRING, MD — Unanimously disappointed with the end point used to determine clinical benefit, advisors to the US Food and Drug Administration (FDA) agreed the Sentinel Cerebral Protection System ...

In the first head-to-head comparison of two devices intended to protect against stroke in patients undergoing transcatheter aortic valve replacement (TAVR), the investigational Emboliner device ...

NEW ORLEANS — The first embolic protection device designed to prevent periprocedural debris from entering any of the three cerebral vessels or the descending aorta during transcatheter aortic valve ...

NEW ORLEANS, LA—The novel Emboliner protection device (Emboline) provides comparable results to those obtained with the Sentinel cerebral protection system (Boston Scientific) when used during ...

PROTECT H2H is the first randomized IDE trial of an embolic protection device in TAVR to meet all primary and secondary safety and efficacy endpoints, representing a significant clinical and regulator ...