EBR Systems, Inc. (ASX: EBR) is confident its pivotal SOLVE-CRT Investigation Device Exemption (IDE) study will be able to include commercially available leadless pacemakers as co-implants for the WiSE CRT System to deliver cardiac resynchronisation therapy (CRT) for eligible patients.
We are pleased to be able to include leadless pacemakers as co-implants in our pivotal SOLVE-CRT clinical trial,” John McCutcheon, CEO and President of EBR Systems, said.
“This exciting development has the potential to meet a significant unmet clinical need by providing a solution to physicians whose patients with leadless pacemakers have no other upgrade options.
“Leadless pacemakers represent a fast-growing market in cardiac rhythm management and this update makes WiSE the only device that can potentially support the upgrade of patients currently implanted with a leadless right ventricle pacemaker.
“If approved for final labelling during the PMA application, the opportunity to pair leadless pacemakers with the WiSE CRT System to deliver biventricular pacing therapy expands EBR’s initial addressable market by US$400m with further growth potential as other leadless pacemakers come to market.
“The SOLVE-CRT pivotal trial remains on track to complete recruitment as scheduled. In addition, we look forward to initiating our Totally Leadless CRT (TLC) Study in Australia and Europe, which builds on our dataset of patients treated with WiSE and leadless pacemakers.”
WiSE is the only leadless, inside-the-left-ventricle-of-the-heart pacemaker that can be used in conjunction with a right ventricle pacemaker to deliver CRT (biventricular pacing) to patients suffering from heart failure.
The SOLVE-CRT pivotal trial was originally designed only to include patients with conventional pacemakers (with a lead to the right ventricle).
This update expands the patient pool for the SOLVE-CRT trial to include patients with a leadless right ventricle pacemaker, that can be paired with the WiSE System to deliver CRT.
While future labelling is subject to multiple factors including regulatory approvals, the inclusion of leadless pacemakers in the SOLVE-CRT trial indicates the FDA will consider whether to approve the WiSE CRT System for use with wireless pacemakers as on-label treatment (i.e. FDA-approved treatment option) at the time of PMA (Pre-market Approval) application.
Lastly, the funding requirements, key endpoints, and timing of the SOLVE-CRT trial will not be impacted by this development with enrolment for interim analysis still expected to complete by H1 2022.
