Tag: EBR Systems

Positive results from first-in-human completely leadless CRT in the US, published in The Journal of the American College of Cardiology

SUNNYVALE, Calif., Oct. 25, 2023 /PRNewswire/ — EBR Systems, Inc. (ASX:EBR), the medical device company developing wireless cardiac pacing systems, is proud to announce that positive results from the first completely leadless cardiac resynchronization therapy (CRT) in the United States…

EBR Systems’ Pivotal SOLVE-CRT Trial Meets Endpoints: Excellent Interim Analysis Results Lead to Early Trial Halt for Success

Data Presented at Late-Breaking Session at Heart Rhythm Society 2023: Paves Way for Premarket Approval Application for Federal Drug Administration Approval and Commercialisation The pivotal SOLVE-CRT study evaluated EBR Systems’ WiSE® CRT System, the world’s first and only wireless, inside […]

FDA Grants EBR Systems Breakthrough Device Designation Status for the WiSE Cardiac Resynchronization Therapy (CRT) System

SUNNYVALE, Calif.–(BUSINESS WIRE)–EBR Systems, Inc., developer of the world’s only wireless cardiac pacing system for heart failure, today announced that the U.S. Food and Drug Administration (FDA) has granted BreakthrouThe FDA created this designation and its associated program in 2017 […]