#United States #Austin, Texas #Heart Failure #WiSE System #EBR Systems

First Commercial Implants of the WiSE System for CRT Patients

In an unprecedented move in the world of cardiology, the first commercial patients in the United States have successfully received implants of the WiSE® System, a groundbreaking technology in heart failure treatment. This development represents a defining moment for patients struggling with heart failure, a condition that impacts millions and often leaves them with few treatment options.

What is the WiSE System?

The WiSE System stands apart as the first and only leadless device that delivers Left Ventricular Endocardial Pacing (LVEP). Unlike traditional methods that require wires implanted into the coronary sinus, the WiSE System uses a miniaturized electrode that is implanted directly into the endocardium of the left ventricle. This advancement mimics the heart's natural electrical activation, allowing for more efficient pacing and potentially better outcomes for patients.

Dr. Robert Canby, a leading physician involved in the procedure, commented on the significance of this moment: "Treating our first commercial patient was a powerful moment. We can now offer a leadless LVEP option to individuals who were either unable to receive left ventricular pacing or whose previous therapies failed. This method eliminates the need to navigate through the coronary sinus, marking a significant breakthrough in our approach to heart failure treatment."

The Procedure and Initial Results

The first of these significant procedures was performed at St. David's Medical Center in Austin, Texas, a leading institution taking part in the initial market release of the WiSE System. Simultaneously, Cleveland Clinic joined in the effort with an additional implant conducted by Dr. Niraj Varma.

Dr. Varma praised the technique, stating, "Endocardial pacing closely resembles the heart’s natural activation. The WiSE System allows us to deliver pacing without the need for leads, which can enhance synchrony and improve overall patient outcomes."

This innovative device was validated through rigorous studies, including the SOLVE-CRT pivotal trial, where it demonstrated promising results such as reverse remodeling and notable improvements in left ventricular function among patients with heart failure classified as NYHA II-IV. The clinical results are now transitioning from research to real-world applications, paving the way for better patient experiences.

Ongoing Developments and Future Plans

With the introduction of these first commercial implants, Erik Strandberg, Chief Commercial Officer of EBR Systems, expressed confidence about the future. "We are not just performing procedures; we are initiating a new chapter in left ventricular pacing that brings fresh hope to patients who have exhausted their options. The enthusiasm from the medical community underscores the momentum we are fostering to bring the WiSE technology to those in need."

EBR Systems plans to continue a phased rollout for the WiSE System throughout the year 2025, working closely with select centers specializing in Cardiac Resynchronization Therapy (CRT) and leadless pacing solutions. A broader commercial launch across the United States is anticipated in 2026.

As John McCutcheon, President and CEO of EBR, remarked, "Witnessing the WiSE System in action within clinical settings and making a difference in the lives of heart failure patients is profoundly rewarding. It's a proud moment for our team, and we are honored to collaborate with such skilled physicians in this endeavor."

About EBR Systems

EBR Systems is a pioneering medical device company aiming to enhance heart failure treatments through innovative leadless pacing technology. Headquartered in Sunnyvale, California, EBR is committed to advancing cardiac health solutions with a patient-first approach, working tirelessly to support physicians and improve the quality of life for patients affected by heart failure. For more information about their solutions, visit EBR Systems' official site.