#USA #Arkansas #Heart Failure #WiSE System #EBR Systems

EBR Systems Achieves First Enrollments in the WiSE-UP Study for Heart Failure Patients

On November 7, 2025, EBR Systems Inc., a pioneer in cardiac rhythm technology, announced a significant development in heart failure treatment with the initiation of the WiSE® System Utilization Performance (WiSE-UP) Study. Conducted at St. Bernards Heart and Vascular Center in Arkansas, the study has already enrolled its first two patients, a notable accomplishment led by Dr. Devi Nair, a renowned electrophysiologist. This post-approval study aims to collect real-world evidence of the WiSE® System's effectiveness in patients who are unable to receive traditional cardiac resynchronization therapy (CRT).

The WiSE-UP Study's ambitious plan includes following more than 300 heart failure patients across 50 medical centers in the United States over the next five years. Through its observational approach, the study will seek to gather both short-term and long-term performance metrics related to this innovative therapy. The ultimate goal is to bolster evidence supporting the use of left ventricular endocardial pacing (LVEP) for improved patient outcomes.

The WiSE® System represents a groundbreaking advancement in the field of cardiac pacing. It is the first FDA-approved system allowing leadless LVEP, which provides a non-invasive solution to patients for whom conventional CRT may not be suitable. Dr. Devi Nair expressed her pride in being part of this fundamental step in cardiac therapy, emphasizing that the study will enhance our understanding of the tool's benefits for heart failure patients. Furthermore, she reiterated the team's commitment to advancing innovation in therapeutic techniques for heart conditions.

Dr. Niraj Varma, a key figure in the study and Professor of Medicine at the Cleveland Clinic, echoed Dr. Nair’s enthusiasm for the WiSE-UP Study's potential. He highlighted the importance of capturing clinical outcomes and assessing the efficacy of the WiSE System in real-world environments. The study's results are anticipated to shape the standards of care for heart failure treatment based on empirical evidence from diverse patient experiences.

The WiSE Technology Explained

The WiSE System is remarkable in its design. It delivers LV endocardial pacing without the need for a transvenous lead, employing a targeted ultrasound mechanism instead. The setup includes a subcutaneous transmitter and battery that detect the right ventricle pacing signal, converting it into an electrical pulse to enable synchronized biventricular pacing. This versatility makes it a groundbreaking option for patients with varying anatomical challenges who previously faced limited options for effective treatment.

As EBR Systems continues to advance its mission to transform the lives of heart failure patients, the WiSE-UP study is poised to be a watershed moment, providing critical insights that could refine treatment protocols and improve patient care in the realm of cardiac health. The study's execution will not only contribute to scientific knowledge but is expected to inspire confidence among healthcare providers and patients alike regarding innovative heart treatment options.

For further information about EBR Systems and the WiSE technology, visit EBR Systems Inc..