FDA Approves WiSE® System, World's First and Only Leadless Left Ventricular Endocardial Pacing (LVEP) Device for CRT

Every once in a while, a breakthrough doesn't just advance medicine—it changes the conversation entirely.

SUNNYVALE, Calif., April 17, 2025 /PRNewswire/ -- EBR Systems, Inc. (ASX: EBR) has received FDA approval of the WiSE^® System, which marks a significant leap forward in the treatment of heart failure. Unlike conventional CRT, the WiSE System is the first and only to deliver leadless left ventricular endocardial pacing (LVEP), that closely aligns with the heart's natural conduction pathway. The endocardial approach represents a more physiological method of resynchronization and allows electrophysiologists to treat patients that are not able to receive lead-based devices. This advancement offers a pioneering treatment option for patients who have limited access to conventional CRT therapies.

"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, PhD, 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."

Expanding Access to Patients

Conventional CRT leaves too many heart failure patients behind. The WiSE System was designed for them. It allows physicians to help these key patient populations:

• 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
  
  
• Patients with leadless pacemakers* who need CRT, yet are often poor candidates for conventional upgrades

In short: WiSE brings CRT to more patients than ever before.

Backed by Data. Reimagining Delivery of CRT.
The SOLVE-CRT trial has delivered promising results for heart failure patients. The WiSE System offers hope to those who have tried other therapies without success and were told no further options existed—until now.

• 16.4% reduction in LV end-systolic volume (LVESV)—a key marker of reverse remodeling (p=0.003)
  
  
• Shorter QRS durations by an average of 39ms— an indicator of electrical resynchronization
  
  
• Over 55% improved at least one NYHA class and another 40% remained stable

Seamless Integration.

The WiSE System syncs with existing pacing devices—pacemakers, ICDs, or CRTs—using a subcutaneous ultrasound Transmitter to power an ultra-compact Electrode implanted in the LV.

No leads. No lead navigation. Just endocardial pacing that's more physiologic, from the inside out.

Empowering Physicians, Powering Hearts.

"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."

For more information about training, patient selection, or clinical support, please contact EBR at www.ebrsystemsinc.com.

*Medtronic's Micra leadless pacemaker has been qualified for use with WiSE System. Abbott's Aveir leadless pacemaker has not yet been qualified for use with WiSE System, but testing conducted by EBR is in progress.

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SOURCE EBR Systems