EBR Systems (ASX:EBR) has achieved a significant milestone with its WiSE CRT System as the U.S. Food and Drug Administration (FDA) has completed its initial filing review of the premarket approval (PMA) application and determined that it contains all the required information to proceed to a substantive review. The WiSE CRT System is the world’s first leadless pacemaker for the heart’s left ventricle.
The substantive review is a comprehensive evaluation process of the full PMA application, including a Bioresearch Monitoring (BIMO) audit to ensure the quality and integrity of EBR’s clinical trial study data and a Pre-Approval Inspection (PAI) to confirm EBR’s manufacturing, processing, and packing procedures comply with Quality System regulations.
During the substantive review, the FDA will provide feedback and request responses from the company before a decision regarding the approvability of WiSE. EBR’s PMA application includes extensive technical documentation and comprehensive clinical data from all clinical trials to date, including data from the pivotal SOLVE-CRT trial, which successfully met its primary efficacy and safety endpoints. Results of the SOLVE -CRT trial were released at the Heart Rhythm Society’s May 2023 conference and were recently published in the journal JAMA Cardiology.
WiSE has been designated a Breakthrough Device, allowing EBR to receive prioritized review and interactive communication with the FDA. The company anticipates FDA approval in Q1 CY2025, remaining on track for commercial launch in CY2025.
EBR president and CEO John McCutcheon said it was a significant milestone for the company that its PMA application had progressed to substantive review by the FDA, effectively moving into the final stages of its regulatory timeline. "This significant milestone brings us even closer to commercialisation and to making available our life-changing WiSE technology to heart failure patients in need."
