EBR Systems Obtains FDA Approval to Begin Study of Wireless Cardiac Pacing System for Heart Failure

EBR Systems has been granted an Investigational Device Exemption (IDE) by the FDA for its WiSE (Wireless Stimulation Endocardially) Technology for cardiac resynchronization therapy (CRT).

The company’s device is designed as an endocardial pacing system for stimulating the heart’s left ventricle.

In a study of 35 patients for whom conventional CRT therapy had failed, 97 percent were implanted successfully with the device. Of the thirty-three patients who reached the six-month effectiveness endpoint, 85 percent witnessed improvement. — Cynthia Jessup