First Patient Implanted in EBR’s Leadless CRT Study Targeting 75% CRT Market

A Milestone in Leadless Cardiac Therapy

EBR Systems, a Silicon Valley-based medical device company, has announced a significant clinical milestone with the first patient implant in its Totally Leadless CRT (TLC-AU) study. The procedure was successfully performed at the Princess Alexandra Hospital in Brisbane by Dr Paul Gould, a respected electrophysiologist. This study explores the use of EBR’s WiSE wireless cardiac pacing system in combination with a leadless pacemaker to deliver cardiac resynchronisation therapy (CRT) without traditional pacing leads.

Expanding the Reach of Wireless CRT

CRT is a critical treatment for heart failure patients who require coordinated pacing of the heart’s ventricles. Traditionally, this therapy involves leads placed on the heart’s surface, which can cause complications and limit effectiveness. EBR’s WiSE technology, which stimulates the left ventricle wirelessly from inside the heart, aims to overcome these challenges. The TLC-AU study is particularly notable because it targets newly diagnosed patients needing CRT for the first time, a group that represents approximately 75% of the CRT market.

Study Design and Strategic Implications

The feasibility study will enroll between 20 and 40 patients across up to five Australian centers. It includes both patients receiving CRT de novo and those upgrading from existing intracardiac pacemakers. Over a six-month follow-up period, the study will assess safety, efficacy, and clinical response to the totally leadless CRT approach. This research builds on prior FDA-approved indications for WiSE as an upgrade therapy and aims to establish the system as a frontline treatment option.

Leadership Perspective and Market Potential

John McCutcheon, President and CEO of EBR Systems, highlighted the importance of this milestone in positioning WiSE CRT as a fully leadless alternative for patients requiring resynchronisation therapy. As leadless pacing gains traction as the standard of care, EBR’s technology could lead the next evolution in heart failure treatment. Dr Paul Gould emphasized the potential of the study to expand treatment options and provide valuable clinical insights into totally leadless CRT.

Looking Ahead

While the TLC-AU study is early stage and focused on feasibility, its outcomes could have far-reaching implications for the cardiac device market. Success would not only validate the safety and efficacy of a leadless CRT system but also open the door to a larger patient population and new commercial opportunities for EBR Systems.