- WiSE CRT is the first leadless CRT system to win FDA pre-market approval.
- 117 US commercial procedures completed by the end of Q2 2026.
- Master purchasing agreements signed with three of the top 10 US purchasing groups.
- CMS has opened a national coverage analysis under the TCET pathway.
EBR Systems holds the world’s only FDA-approved leadless cardiac resynchronisation system. Having passed its 100th US commercial implant, EBR is scaling into a US$5.8 billion market as a national Medicare coverage review runs in parallel.
In April 2025, EBR Systems (ASX:EBR) won US FDA pre-market approval for a cardiac resynchronisation system free of leads.
Cardiac resynchronisation therapy has saved and extended lives for over two decades. It works by pacing both ventricles of a failing heart back into step.
The catch has always been the wiring.
EBR’s WiSE CRT system removes the lead from the equation. In its place sits an electrode about the size of a cooked grain of rice, implanted inside the left ventricle and powered by ultrasound from a transmitter positioned between the ribs.
It is the only wireless endocardial left-ventricular pacing system in clinical use anywhere in the world, and the only leadless CRT system commercially available in the United States.
The patients conventional CRT could not reach
A standard CRT device restores coordination between the ventricles by pacing both. The left-ventricular lead reaches its target through a vein running across the outside of the heart.
That route doesn’t work for everyone. Some patients have venous anatomy that will not accept the lead. Others receive one and see it fail. A further group already carries a pacemaker or defibrillator and needs an upgrade that adding another lead would make hazardous. And a well-documented share of patients receive a conventional CRT device and do not respond to it.
WiSE was designed for precisely those groups. Because it paces the inner wall of the left ventricle rather than the outer surface, it stimulates the heart in a way that more closely resembles the organ’s own conduction. And because there is no lead, the complications that come with leads are not part of the picture.
EBR sizes the initial addressable opportunity at US$5.8 billion, spanning three categories: high-risk upgrades, lead failure, and broader expansion of leadless CRT. That figure covers the currently approved indication, with the company flagging additional indications as a longer-dated opportunity.
From world-first approval to commercial launch
FDA approval arrived on 11 April 2025. The company followed with a deliberately narrow limited market release in late 2025, then broadened the rollout through 2026.
EBR completed 18 commercial cases in the December 2025 quarter. By the end of the June 2026 quarter, it had passed its 100th commercial implant, closing the half with 87 implants across 29 hospitals and 117 WiSE procedures in total.
Speaking to The Stock Network about the commercial rollout, president and chief executive John McCutcheon pointed to hospital contracting as the metric to watch closely.
EBR Systems president and CEO John McCutcheon on the US commercial rollout following FDA approval of the WiSE CRT system.
He also described a response from clinicians that he says is unlike anything in his career in medical devices.
In June 2026, the Centers for Medicare & Medicaid Services opened a national coverage analysis for WiSE under the Transitional Coverage for Emerging Technology pathway, a route created to shorten the gap between FDA approval and full Medicare coverage for breakthrough devices.
Chief corporate development officer Andrew Shute on the $150 million capital raise, the CMS coverage process and new healthcare network agreements.
The company has signed master purchasing agreements with HCA Healthcare, Advocate Health and CHRISTUS Health. Shute describes all three as sitting inside the top 10 purchasing groups in the United States.
The practical effect is that a sales representative arriving at a hospital inside one of those networks no longer has to shepherd a fresh contract through that institution’s administration before a case can be booked.
EBR is also changing how it builds the device. A new facility is coming online progressively through 2026.
A device with a US$63,300 list price built in low volumes by third parties could carry a materially different cost profile to the same device produced at scale in-house.
Inside the procedure
Implanting an electrode inside a beating left ventricle asks a great deal of the operator, and EBR has continued refining the tooling as more centres come online. One recent addition is the WiSE Coupler, an optional accessory that stabilises the delivery system during electrode implantation.
Dr Anne Kroman, DO, PhD, director of the electrophysiology lab and cardiac device program at the Medical University of South Carolina, described where it fits in the workflow.
Dr Anne Kroman of the Medical University of South Carolina on the coupler accessory and the WiSE implant procedure.
Her wider point concerns what happens as the procedure moves from a small group of expert operators to a broad community of implanters.
The WiSE Coupler was built specifically to make electrode implantation easier as more physicians take up the procedure. Physician feedback from the field shaped the coupler design, as senior director of R&D Mark Hirotsuka explains.
EBR Systems senior director of R&D Mark Hirotsuka on why the WiSE Coupler was developed and how physician feedback shaped its rollout.
Hirotsuka says feedback since the full US launch has been positive, with physicians ranking the coupler workflow easy or very easy.
Data presented at Heart Rhythm 2026 tracks that progression. EBR reported a complication rate of 10% in real-world commercial implants, compared with 19.1% observed in the SOLVE-CRT clinical study.
What the company expects next
Asked what to watch from here, Shute nominated two things:
- Continued revenue growth, drawn both from opening new accounts and from deeper utilisation at hospitals already contracted.
- Improvement in cost of goods as the company moves into 2027 and 2028.
Alongside those sit the outcome of the CMS national coverage analysis, and the pace at which the three network purchasing agreements convert into active implanting sites.
Seventeen months on from an approval no other company holds, in a category it created, EBR Systems is now doing the work of turning a world-first into a standard of care.
This article was produced in collaboration with the company featured and the information provided is for general information purposes only and should not be considered financial advice. Readers should consider their own circumstances and seek independent professional advice before making any investment decisions.