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 the left ventricle of the heart, pacing system for heart […]
Tag: WiSE CRT
EBR Systems’ WiSE CRT System Demonstrates Technical Feasibility of Leadless Left Bundle Branch Area Pacing for Cardiac Resynchronization
New Case Report Reveals Opportunity to Become First-Line Therapy for Patients SUNNYVALE, Calif.–(BUSINESS WIRE)–EBR Systems, Inc., developer of the world’s only wireless cardiac pacing system for heart failure, today announced the publication of a case report demonstrating the WiSE™ CRT System’s ability to successfully deliver leadless Left Bundle Branch Area Pacing […]
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 for certain devices providing more effective treatment of life-threatening or […]
EBR Systems Awarded Prestigious Forfait Innovation Package for WiSE CRT System by French Ministry of Social Affairs and Health
SUNNYVALE, Calif., July 22, 2019 /PRNewswire/ — EBR Systems, Inc., developer of the world’s only wireless cardiac pacing system for heart failure, today announced that the College of the French National Authority for Health (Haute Autorite de Sante, HAS) awarded a Forfait Innovation Package for the company’s WiSE™ Cardiac Resynchronization Therapy (CRT) System. […]