EBR Systems Advances Toward Australian Market with WiSE CRT System
EBR Systems is making significant progress in its efforts to bring the WiSE cardiac resynchronisation therapy (CRT) system to Australia. The company has recently received a Priority Review Determination from the Therapeutic Goods Administration (TGA), which could fast-track the device’s approval and make it available to patients in need more quickly.
This development marks an important milestone for EBR, as it continues to expand its global presence. The WiSE system is designed to provide left ventricular stimulation without the use of traditional leads, offering a new option for patients who may not benefit from conventional CRT devices.
What is the Priority Review Determination?
The TGA’s Priority Review pathway is reserved for medical devices that address life-threatening or seriously debilitating conditions with high unmet needs. By granting this designation, the TGA is effectively shortening the evaluation timeline from 225 working days to approximately 150 days. This means that if EBR submits its application for inclusion on the Australian Register of Therapeutic Goods (ARTG), the process could be significantly accelerated.
The decision comes as EBR continues to build momentum in the United States, where the WiSE system was approved by the Food and Drug Administration (FDA) in April 2025. The company has already seen early commercial success, with 41 patients implanted with the system during the first quarter of 2026. This represents more than double the number of implants from the previous quarter, bringing the total number of implants across the pilot phase and limited market release to 71.
Expanding Access Beyond the US
President and CEO John McCutcheon highlighted the significance of the TGA’s decision, stating that it builds on the growing regulatory and commercial momentum the company has achieved in the US. He emphasized that the WiSE system offers a differentiated leadless CRT option for patients who cannot receive or do not respond to conventional lead-based therapy.
“Receiving Priority Review Determination from the TGA is an important step in expanding access to the WiSE System beyond the US and reflects the potential of this technology to address a significant unmet need for heart failure patients in Australia,” he said.
McCutcheon also noted that with FDA approval secured, early US commercial momentum building, and growing clinical validation, the WiSE system is well-positioned to make a meaningful impact in Australia.
Next Steps for EBR
EBR plans to submit its ARTG application in the near term, with the goal of securing approval and opening the door to earlier access for heart failure patients in Australia. The company is currently working closely with the TGA to navigate the review process and ensure that the WiSE system meets all necessary regulatory requirements.
The WiSE system is unique in its approach, as it eliminates the need for leads, which can sometimes cause complications for patients. This makes it an attractive option for those who have exhausted other treatment options.
Conclusion
With the TGA’s Priority Review Determination, EBR Systems is one step closer to introducing the WiSE CRT system to the Australian market. This development highlights the potential of the technology to improve outcomes for heart failure patients who have limited treatment options. As the company continues to advance its global rollout, it remains focused on delivering innovative solutions that meet the needs of patients and healthcare providers alike.
