EBR Systems, Inc. announced that its pivotal SOLVE-CRT Investigation Device Exemption study will be able to include commercially available leadless pacemakers as co-implants for the WiSE CRT System to deliver cardiac resynchronisation therapy for eligible patients. 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.

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 at the time of PMA 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 first half 2022.