EBR Systems submits final PMA application to US FDA for WiSE CRT System [Video]

EBR Systems Inc (ASX:EBR) president and chief executive officer John McCutcheon joins Proactive’s Tylah Tully to discuss the submission of a final Pre-Market Approval (PMA) module to the US FDA for its WiSE CRT System, marking a significant milestone in the company’s commercialisation pathway.
The final PMA application module will undergo an initial filing review period to ensure administrative completeness and adequacy of technical elements before the FDA conducts a substantive review.
The WiSE System has received Breakthrough Device designation, allowing EBR to benefit from prioritised review and interactive communication with the FDA throughout the PMA process. WiSE is the world’s only wireless cardiac pacing device for heart failure, addressing a patient population with no current treatment options and potentially improving conditions for millions of patients.
EBR anticipates FDA approval in the first quarter of 2025 and remains on track for a commercial launch next year in the substantial US market, valued at US$3.6 billion.
The PMA application includes extensive technical documentation and clinical data, notably from the pivotal SOLVE-CRT trial, which met its primary safety and efficacy endpoints.
Following approval, EBR will focus on driving adoption of the WiSE System at key, high-volume procedure sites across the US.
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