EBR Systems (ASX: EBR) has hit a huge milestone, announcing FDA approval for its WiSE® CRT System—the world’s first and only leadless solution for left ventricular pacing in cardiac resynchronization therapy (CRT). This green light opens the door to treating a significant number of heart failure patients previously left without viable CRT options.
For the first time, clinicians will be able to deliver CRT without leads in the left ventricle. That’s a game-changer for patients who can’t be treated with conventional lead-based systems due to failed procedures, anatomical challenges, or high surgical risk.
The FDA approval was built on years of clinical development, a robust Premarket Approval (PMA) process, and a successful inspection of EBR’s manufacturing facilities in January—with no red flags raised. With approval granted on 11 April 2025, EBR is ready to transition from R&D to revenue, eyeing a US$3.6 billion initial addressable market across high-risk upgrades, failed lead cases, and CRT expansion into the leadless space.
CEO John McCutcheon called the approval a “transformative moment,” saying the company is now set to bring a long-awaited alternative therapy to the market. A focused, limited rollout will begin in late 2025, followed by a full commercial launch in early 2026.
Importantly, EBR has designed WiSE to work with existing pacemakers and defibrillators, including Medtronic’s Micra leadless pacemaker. Testing is also underway to qualify Abbott’s Aveir system. The company is also laying the groundwork for success by expanding its commercial team, refining clinical workflows, and rolling out comprehensive training programs to support high-volume centers from day one.
As part of its FDA breakthrough designation, EBR is expected to qualify for US reimbursement programs including the NTAP (for inpatients) and TPT (for outpatients), with both expected to kick in from October 2025.
In short, FDA approval not only validates the WiSE CRT System—it puts EBR firmly on the path toward revenue growth and market leadership in leadless cardiac pacing.
