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FDA Grants EBR Systems Breakthrough Device Designation Status for the WiSE Cardiac Resynchronization

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 Breakthrough Device Designation for the WiSE CRT System for the treatment of heart failure. he FDA created this designation and its associated program in 2017 for certain devices providing more effective treatment of life-threatening or irreversibly debilitating diseases or conditions. Under the program, the FDA will provide EBR with priority review and interactive communication. The WiSE (Wireless Stimulation Endocardially) CRT System is designed to improve the heart’s pumping abili