Search Results

Large Meta-Analysis Compares Second-Generation DES and BMS for Primary PCI in STEMI

November 26, 2013—Findings from a comparison of the clinical outcomes between second-generation drug-eluting stents (DES) and bare-metal stents (BMS) using a network meta-analysis of primary percutaneous coronary intervention (PCI) trials in ST-segment elevation myocardial infarction (STEMI) were published by Femi Philip, MD, et al online ahead of print in Circulation: Cardiovascular Interventions.

Boston Scientific's Sentinel Cerebral Embolic Protection Device Evaluated in Results From PROTECTED TAVR Trial

September 17, 2022—Boston Scientific Corporation announced results from the PROTECTED TAVR clinical trial evaluating the company's Sentinel cerebral embolic protection (CEP) system, which is designed to capture and remove embolic debris in transcatheter aortic valve replacement (TAVR).

SENTINEL Trial Evaluates Claret Medical's Cerebral Embolic Protection Device

November 1, 2016—The multicenter, randomized SENTINEL trial evaluating the role of embolic protection using the Sentinel cerebral protection device (Claret Medical, Inc.) during transcatheter aortic valve replacement (TAVR) found that the device was safe but did not meet the primary efficacy endpoint of reduction in median new lesion volume in protected territories as assessed by magnetic resonance imaging (MRI) at 2 to 7 days.

FDA Clears Claret Medical's Sentinel Cerebral Protection System for TAVR Procedures

June 5, 2017 – Claret Medical, Inc. announced that it has received clearance from the US Food and Drug Administration (FDA) for the Sentinel cerebral protection system (CPS), via de novo classification, enabling commercialization of the device in the United States.

FDA Panel Reviews Claret Medical's Sentinel Cerebral Protection System for TAVR

February 27, 2017—Claret Medical Inc. announced that in an open public hearing of the US Food and Drug Administration's Circulatory System Devices Panel held on February 23, virtually all panel members recommended the de novo application of the company's Sentinel cerebral protection system (CPS) be granted, which would enable commercialization of the device in the United States.