EBR Systems Surpasses 10th US Implant Milestone Ahead of Reimbursement Launch

EBR Systems Hits Key Commercial Implant Milestone

EBR Systems, the Silicon Valley-based innovator behind the world’s only wireless cardiac pacing device for heart failure, has marked a pivotal moment in its US commercial rollout by surpassing ten successful implants of its WiSE System. This milestone, achieved during the pilot launch phase, underscores growing clinical acceptance of the technology among physicians and patients alike.

The WiSE System, designed to stimulate the heart’s left ventricle without the need for traditional pacing leads, offers a novel approach to cardiac resynchronisation therapy (CRT). By eliminating leads, which have historically been a source of complications and reliability issues, WiSE aims to improve patient outcomes and reduce procedural risks.

Strategic Pilot Launch and Clinical Validation

Several implants were performed by Dr. Rahul Doshi at HonorHealth in Arizona, a large nonprofit healthcare system serving millions. EBR’s pilot launch strategy focuses on a limited number of sites with high utilisation rates, mirroring the upcoming limited market release (LMR) planned for October 2025. This approach allows the company to refine clinical workflows and build strong physician partnerships ahead of broader commercialisation.

Dr. Doshi highlighted the clinical advantages of WiSE, noting that left ventricular endocardial pacing is more physiological than conventional epicardial CRT methods. He expressed optimism that once reimbursement top-up payments commence, WiSE will be rapidly adopted for patients who have failed traditional CRT or are at high risk for lead-based upgrades.

Reimbursement Milestones Set to Accelerate Adoption

Crucially, EBR has secured approval for the New Technology Add-On Payment (NTAP) program targeting inpatient procedures, alongside preliminary approval for the Transitional Pass-Through (TPT) program for outpatient settings. Both reimbursement pathways are scheduled to begin in October 2025, coinciding with the LMR. These add-on payments are designed to incentivize hospitals to adopt the WiSE System by offsetting costs, a critical factor for commercial success in the US healthcare market.

John McCutcheon, EBR’s CEO, emphasized that the rapid achievement of the ten-case milestone shortly after FDA approval reflects strong clinical demand and validates the company’s innovative technology. He expressed confidence that the confirmed reimbursement framework positions EBR well to expand its footprint and accelerate market penetration.

Looking Ahead

While the WiSE System remains investigational in most markets outside the US, this milestone and reimbursement progress mark significant steps toward broader commercialisation. Investors and industry watchers will be keen to monitor implant volumes, reimbursement uptake, and any updates on outpatient coverage as EBR moves beyond its pilot phase.