EBR’s has submitted the final module for its PME application to the FDA. Pic: Getty Images .
Health & Biotech
Special Report: EBR Systems has submitted the final premarket approval (PMA) application module to the US Food and Drug Administration (FDA) for its WiSE CRT System, which holds the distinction of being the world’s first leadless pacemaker for the heart’s left ventricle.
EBR Systems (ASX:EBR) has announced it has completed and submitted the final PMA module to the FDA for its WiSE CRT (Cardiac Resynchronization Therapy) System, marking a significant milestone for the company.
The submission of EBR’s PMA application for the WiSE System moves EBR closer to commercialising the world’s first wireless pacemaker for the left ventricle in the US, with a market valued at US$3.6bn.
The WiSE System allows clinicians to address the needs of a patient population that currently has no other treatment options, potentially improving the condition of millions of patients.
Given the review cycle of a PMA application, EBR said it anticipates approval in Q1 CY25 and remains on track for a commercial launch in US next year.
The company said the commercial launch will focus initially on driving adoption of WiSE at key, high volume procedure sites in the US.
EBR said 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.
Following the completion of this stage, the FDA will notify the company if their application has been accepted for substantive review.
EBR said the substantive review is a comprehensive evaluation process of the full PMA application, with key assessments including:
EBR’s PMA application includes extensive technical documentation and clinical data from all its clinical trials to date.
This includes EBR’s pivotal SOLVE-CRT trial, which successfully met its primary safety and efficacy endpoints.
EBR said the company’s breakthrough device designation for WiSE will enable EBR to receive prioritised review and interactive communication with the FDA throughout the PMA process.
EBR announced positive top-line data from its pivotal SOLVE -CRT trial at the Heart Rhythm Society’s May 2023 conference.
Positive results from the SOLVE randomised sub-study were presented at the Asia Pacific Heart Rhythm Society conference in September 2023, further reinforcing conclusions from the primary study.
Additionally, the company this month announced that results from its SOLVE trial had been published in JAMA Cardiology, an international peer-reviewed journal.
EBR president and CEO John McCutcheon said the submission reflects years of dedicated effort and collaboration among our clinical, regulatory, and engineering teams.
“We are thrilled to have reached this significant milestone in our company’s journey,” he said.
“With this application, we are now one step closer to making WiSE available to physicians and their patients across the United States.
“If approved, this PMA package will enable us to launch WiSE in 2025.”
Chief regulatory officer Madhuri Bhat said the PMA application represents a pivotal step in EBR’s clinical and regulatory process, highlighting its commitment to meeting all FDA requirements.
“EBR has consistently maintained an open and collaborative dialogue with the FDA throughout the application process to ensure that our submission adheres to the Agency’s high standards,” Bhat said.
“We are confident that any inquiries during the review period will continue in the same spirit of constructive dialogue to support a positive review.”
This article was developed in collaboration with EBR Systems, a Stockhead advertiser at the time of publishing.
This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.
Health & Biotech
Health & Biotech
Health & Biotech
