cardiac-resynchronization-therapy
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EBR Systems, Inc.
EBR Systems is a Sunnyvale, California medical device company that developed the WiSE System, the world's first and only leadless left ventricular endocardial pacing device for cardiac resynchronization therapy. About the size of a grain of rice, the ultrasound-powered electrode paces the inside of the heart's left ventricle without wires, working alongside a patient's existing pacemaker or defibrillator. After its pivotal SOLVE-CRT trial was halted early for success, the WiSE System won U.S. FDA approval in April 2025 and began its commercial launch for heart failure patients who have run out of conventional options.
John McCutcheon
John McCutcheon is President, CEO, and Director of EBR Systems, Inc., the Sunnyvale-based medical device company behind the WiSE CRT system - the world's first FDA-approved leadless solution for left ventricular pacing. With over 40 years in medical device sales, marketing, and general management, McCutcheon has shepherded EBR through pivotal clinical trials, FDA Breakthrough Device Designation, and the landmark FDA approval in April 2025. Before EBR, he led Ceterix Orthopaedics to a $105 million acquisition by Smith & Nephew. He brings a track record of building and selling medical device companies, now steering EBR's commercial launch of a technology that could transform how heart failure patients receive cardiac resynchronization therapy.