• EBR Systems has a US FDA manufacturing pre-approval inspection scheduled for the week of January 6, 2025
• Inspection follows:
  • start of substantive review process of pre-market approval submission for the WiSE CRT system
  • Day-100 Meeting scheduled for December 20, 2024.
• WiSE holds distinction of being the world’s first leadless pacemaker for heart’s left ventricle

Special Report:  Medtech EBR Systems (ASX:EBR) will kick off the new year with a manufacturing pre-approval inspection (PAI) with the US Food and Drug Administration (FDA), which has been scheduled for the week commencing January 6, 2025. 

The key milestone follows the FDA’s start of its substantive review process of EBR’s pre-market approval (PMA) submission for its WiSE CRT (cardiac resynchronisation therapy) System in late September.

An upcoming Day-100 Meeting with the regulator following the start of the substantive review is scheduled for December 20.

Silicon Valley-based EBR said the key purpose of the PAI was to confirm manufacturing, processing and packing procedures comply with quality system regulations and its facility can consistently produce devices that meet the approved specifications.

The PMA application for WiSE underwent an initial review by the regulatory body to confirm administrative completeness and adequacy of the technical elements.

The PMA was then accepted for a substantive review in September with the application including extensive technical documentation and comprehensive clinical data from all clinical trials to date.

It included information from its pivotal SOLVE-CRT trial, which successfully met its primary efficacy and safety endpoints.

The substantive review involves comprehensive evaluation, feedback and information requests prior to an approval decision.

EBR said as previously disclosed, the FDA indicated that an onsite Biomedical Monitoring audit will not likely be a requirement before final approval.

Breakthrough device designation enables prioritised review

The size of a grain of rice, the WiSE CRT system holds the distinction of being the world’s first leadless pacemaker for the heart’s left ventricle.

EBR has received breakthrough device designation for WiSE enabling the company to receive prioritised review and interactive communication until completion of the review process.

EBR said the scheduling, initiation and completion of these regulatory requirements continue the WiSE CRT system’s progression through the FDA’s pre-market approval process.

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.