Posted: 14th April 2025
Melbourne-based organisation EBR Systems proudly announces that the U.S. Food and Drug Administration (FDA) has granted approval for its WiSE® CRT System. This groundbreaking system is the world’s first and only leadless solution for left ventricular endocardial pacing, offering a new hope for heart failure patients who cannot be treated with conventional lead-based systems.
The FDA approval marks a significant milestone for EBR Systems, and the greater health technologies sector in Victoria and Australia. The WiSE CRT System addresses a critical unmet need in cardiac resynchronization therapy (CRT) by providing an alternative for patients who are unable to receive traditional lead-based CRT. This innovative system is designed to work seamlessly with existing pacemakers, defibrillators, or CRT devices that provide right ventricular pacing.
John McCutcheon, President and CEO of EBR Systems, expressed his excitement: “Securing FDA approval for the WiSE CRT System is a transformative moment for EBR. We are well-positioned to bring our innovative solution to market, delivering real impact to patients and addressing a significant unmet need.”
EBR Systems plans a phased market release, starting with a limited launch in late 2025, followed by a full-scale commercial rollout in early 2026.
With an estimated initial addressable market of approximately USD 3.6 billion in the U.S., the WiSE CRT System is poised to revolutionize the treatment of heart failure. EBR Systems is expanding its team, strengthening training programs, and collaborating with hospitals to ensure a smooth and effective rollout.
