FDAnews Device Daily Bulletin
Medical Devices / Submissions and Approvals

EBR Systems Nabs Breakthrough Status for Wireless Cardiac Pacing System

Sept. 12, 2019
A A

EBR Systems’ WiSE (wireless stimulation endocardially) cardiac resynchronization therapy (CRT) device has earned breakthrough designation from the FDA for treating heart failure.

The wireless device synchronizes the heart’s left and right ventricles to more efficiently distribute blood, improving its pumping ability. The system controls pacing through the use of a wireless electrode.

The system is implanted in the left ventricle wall in a minimally invasive procedure, giving better options for pacing locations.

View today's stories