EBR Systems (ASX:EBR) has submitted the final Premarket Approval (PMA) application module for its WiSE CRT System to the U.S. Food & Drug Administration (FDA).
- EBR Systems is the developer of the world’s only wireless cardiac pacing device for heart failure
- The PMA application is subject to an initial filing review period to ensure all necessary information has been completed for the FDA to conduct a substantive review
- Subject to FDA approval, EBR is preparing for a 2025 launch readiness in the sizeable U.S. market, which is valued at around US$3.6 billion.
John McCutcheon, EBR Systems’ President & CEO said: “The submission is the result of years of effort and collaboration between our clinical, regulatory, and engineering teams. With this application, we are now one step closer to making WiSE available to physicians for their patients across the United States. If approved, this PMA package will allow us to launch WiSE in 2025.”