FDA Greenlights EBR Systems’ WiSE CRT System, Wireless Pacemaker

In a major medical milestone, EBR Systems (ASX: EBR) has received FDA approval for its WiSE® CRT System—the world’s first and only leadless cardiac resynchronization therapy (CRT) device designed for left ventricular endocardial pacing. The breakthrough gives EBR a first-mover advantage in a US$3.6 billion addressable market, targeting patients historically left behind by conventional CRT.

The WiSE CRT System enables clinicians to deliver CRT without the need for coronary sinus leads—offering a solution for high-risk patients, those with failed lead placements, or those with leadless pacemakers requiring CRT upgrades. It’s a disruptive alternative in a sector where up to 30% of heart failure patients are not candidates for traditional lead-based CRT systems.

“This is a transformative moment for our company,” said John McCutcheon, EBR’s President and CEO. “FDA approval marks our transition from clinical development to commercialization. We’re now poised to deliver a life-changing therapy to patients who previously had no viable CRT options.”

The FDA’s decision follows a rigorous review of EBR’s Premarket Approval application, including five data modules, a clean pre-approval inspection of manufacturing facilities, and comprehensive clinical safety and performance data. The company also benefits from FDA Breakthrough Device designation—positioning it to tap into premium reimbursement channels including the New Technology Add-on Payment (NTAP) and Transitional Pass-Through (TPT), both expected to activate from October 1, 2025.

A limited market release is slated for late 2025, focusing on high-volume U.S. centres that participated in clinical trials. Full commercial launch is targeted for early 2026. EBR will concurrently run a five-year post-approval study involving 320 patients to collect long-term data and support market expansion.

The system is already compatible with Medtronic’s Micra leadless pacemaker, with ongoing testing for Abbott’s Aveir platform. This interoperability opens up collaborative and competitive dynamics in a rapidly evolving sector.

With heart failure affecting over 6 million Americans and CRT shown to reduce hospitalizations and mortality, EBR’s leadless innovation arrives at a critical juncture. The company’s strategic focus on training, workflow optimization, and phased rollout is designed to support rapid clinician uptake and scalable patient impact.