First Commercial Implants of WiSE System for CRT patients

SUNNYVALE, Calif., June 10, 2025 /PRNewswire/ -- In a major milestone for heart failure treatment, the first commercial patients in the U.S. have been successfully implanted with the FDA-approved WiSE^® System—marking the beginning of a new chapter in leadless left ventricular endocardial pacing (LVEP) for the treatment of heart failure.

The WiSE System is the first and only leadless device to deliver LVEP—offering a more physiological¹ approach that mimics the heart's natural electrical activation by stimulating the endocardial tissue inside the left ventricle. This expands treatment options for heart failure patients who have exhausted conventional therapies.

"Treating our first commercial patient was a powerful moment," said Dr. Robert Canby.
"We can now offer a leadless LVEP option for patients who were either unable to receive left ventricular pacing or whose prior therapies failed. Delivering pacing without navigating the coronary sinus is a major advancement. We're excited to continue building experience with the WiSE technology."

The procedure took place at St. David's Medical Center of Austin in Texas, one of several leading institutions participating in the initial limited market release of the WiSE System.

Unlike conventional LV leads placed in the coronary sinus, the WiSE System delivers pacing via a miniaturized electrode implanted directly into the left ventricular endocardium and activated by ultrasound energy. This direct approach enables more flexible lead placement and expands access to those who were previously considered untreatable.

An additional implant was simultaneously completed by Dr. Niraj Varma at the Cleveland Clinic, another center participating in EBR's limited market release.

"Endocardial pacing is much closer to how the heart naturally activates," said Dr. Varma. "The WiSE System delivers this leadlessly. For many patients, this capability means better resynchronization and improved outcomes."

This leadless endocardial approach, validated in the SOLVE-CRT pivotal trial, demonstrated reverse remodeling and significant improvements in left ventricular function in heart failure patients NYHA II-IV. Now, those results are translated into real-world practice.

"With these first commercial implants, we're not just performing a procedure—we're opening a new chapter for left ventricular pacing that promises hope for patients who've had no other options," said Erik Strandberg, Chief Commercial Officer. "The overwhelming support from physicians shows the momentum building to bring WiSE to those who need it most."

EBR will continue its phased rollout throughout 2025, partnering with select centers experienced in CRT and leadless pacing. A broader U.S. commercial launch is expected in 2026.

"Seeing the WiSE System in clinical use, helping heart failure patients with leadless LVEP, is truly gratifying," said John McCutcheon, President and CEO of EBR. "I'm incredibly proud of our team and honored to be working with these incredible physicians to improve patients' lives."

About EBR

EBR is a medical device company dedicated to advancing heart failure therapy through leadless pacing technology. The company's WiSE System is the first and only FDA-approved solution for leadless left ventricular endocardial pacing (LVEP), designed to overcome the limitations of conventional cardiac resynchronization therapy. Headquartered in Sunnyvale, California, EBR is committed to empowering physicians and improving the lives of heart failure patients worldwide.

Find us at https://www.ebrsystemsinc.com/ and on LinkedIn & X

1. Reddy, V. Y., Miller, M. A., Neuzil, P., Søgaard, P., Butter, C., Seifert, et. al. Cardiac resynchronization therapy with wireless left ventricular endocardial pacing: The SELECT-LV study. Journal of the American College of Cardiology

SOURCE EBR Systems