# 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.

- **Founded:** 2003
- **Headquarters:** Sunnyvale, California, United States
- **Founders:** Debra Echt (Co-founder, Electrophysiologist), Axel Brisken (Co-founder, Ultrasound Scientist), Richard Riley (Co-founder, Pacemaker Engineer)
- **Team size:** approx. 89 employees
- **Products:** WiSE System (Wireless Stimulation Endocardially), WiSE CRT ultrasound transmitter and battery
- **Notable:** First and only FDA-approved leadless left ventricular endocardial pacing (LVEP) device for CRT (April 2025), FDA Breakthrough Device designation for the WiSE CRT System, Pivotal SOLVE-CRT trial met primary safety and efficacy endpoints and was halted early for success (2023)

## Products & services

- **WiSE System (Wireless Stimulation Endocardially)** — The world's first and only leadless left ventricular endocardial pacing (LVEP) device for cardiac resynchronization therapy. A receiver-electrode roughly the size of a grain of rice (2.8 mm diameter, 9.2 mm body length, 0.05 cc) is implanted inside the left ventricle and powered by ultrasound energy from a subcutaneous transmitter, pacing the heart from inside the chamber without a lead. It works alongside a patient's existing pacemaker, defibrillator or CRT device.
- **WiSE CRT ultrasound transmitter and battery** — Subcutaneously implanted transmitter and battery that detect right-ventricular pacing and send an ultrasonic pulse to the endocardial electrode, which converts the sound energy into the electrical stimulus that paces the left ventricle.

## Achievements

- First and only FDA-approved leadless left ventricular endocardial pacing (LVEP) device for CRT (April 2025)
- FDA Breakthrough Device designation for the WiSE CRT System
- Pivotal SOLVE-CRT trial met primary safety and efficacy endpoints and was halted early for success (2023)
- Reported a 16.4% reduction in left ventricular end-systolic volume and 80.9% freedom from Type I complications in SOLVE-CRT
- First commercial U.S. implants of the WiSE System (2025)
- Secured Medicare NTAP and transitional pass-through reimbursement (October 2025)
- Launched the WiSE-UP post-approval heart failure study (November 2025)

## Latest updates

- **2025-04** — FDA approved the WiSE System, the world's first and only leadless left ventricular endocardial pacing device for CRT.
- **2025-06** — First commercial U.S. patients successfully implanted with the FDA-approved WiSE System.
- **2025-10** — Secured Medicare New Technology Add-on Payment (NTAP) and transitional pass-through (TPT) reimbursement.
- **2025-11** — Enrolled first patients in the WiSE-UP post-approval heart failure study.

## Links

- Website: https://ebrsystemsinc.com
- LinkedIn: http://www.linkedin.com/company/ebr-systems-inc-
- Twitter/X: https://twitter.com/EBRSystemsInc

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Last updated: 2026-07-15