FDA Approves Leadless Left Ventricular Endocardial Pacing Device for CRT

EBR Systems has received U.S. Food and Drug Administration (FDA) approval for the WiSE system, the first, only CRT device that delivers leadless left ventricular endocardial pacing (LVEP) that closely aligns with the heart’s natural conduction pathway.

This endocardial approach reflects a more physiological method of resynchronization and lets electrophysiologists treat patients that can’t receive lead-based devices. This includes patients with challenging anatomy where the LV lead could not be implanted, patients with acute or chronic LV lead failure, patients with high procedural risk for LV lead placement, and patients with leadless pacemakers who need CRT yet are often poor candidates for conventional upgrades.

The company’s SOLVE-CRT trial of the WiSE system showed 16.4% reduction in LV end-systolic volume (LVESV), a key marker of reverse remodeling (p=0.003). There were shorter QRS durations by an average of 39 ms, which is an indicator of electrical resynchronization. Over 55% of trial subjects improved at least one NYHA class and another 40% remained stable.

WiSE syncs with existing pacing devices using a subcutaneous ultrasound transmitted to power a compact electrode implanted in the LV.

“Recent years have brought significant advancements in leadless pacing for the right heart, but CRT patients were limited to traditional options—until now,” said principal investigator Niraj Varma, MD, Ph.D., FRCP, Professor of Medicine at Cleveland Clinic. “Now, the WiSE System brings a leadless solution to left ventricular pacing, eliminating the biggest limitation of conventional CRT: the lead. This is a game-changer for patients who were previously untreatable due to anatomy or lead failures.”

“We’re delighted for the heart failure patients who were not treatable with existing CRT lead-based devices,” said John McCutcheon, president and CEO of EBR Systems. “This milestone celebrates the dedication of our team, the support of our shareholders, and empowers electrophysiologists with a vital new tool to help their patients. It marks the culmination of EBR’s 22-year pre-commercial phase and the start of our journey as a high-growth, medical device company.”