Leadless CRT - Wireless Stimulation Endocardially (WiSE)

CMS NCA document | source_status=Open | review_type=New | public_comment_open=False | document_id=CAG-00471N

Issue: Heart failure (HF) is a highly prevalent and serious syndrome of cardiac dysfunction. Therapeutic options for HF include both pharmacological and non-pharmacological treatments, such as cardiac resynchronization therapy (CRT) devices aimed at synchronizing ventricular contractions. While there is no cure for HF, pharmacological and non-pharmacological treatments, alone and combined – and including traditional CRT – have been demonstrated in trials to improve survivability, HF symptoms, quality of life, and reduce HF hospitalizations. The WiSE CRT system seeks to extend these benefits to patients for whom traditional CRT has been unsuccessful, ineffective, or deemed too high risk a procedure for the patient. The WiSE CRT system is an implantable cardiac pacing system that aims to provide leadless left ventricular endocardial pacing for CRT delivery in patients with HF. Given that the WiSE CRT system does not use wires or leads to stimulate cardiac pacing, the device is designed to offer treatment to HF patients who meet indications for, but cannot otherwise receive, CRT. The WiSE CRT system is used in conjunction with other cardiac implant devices, as it cannot deliver standalone cardiac rhythm therapy. WiSE CRT intervention is indicated for those who have already undergone an implantation procedure with a right ventricular pacing system that will be upgraded to the WiSE CRT System, or who are eligible for a co-implantation procedure for CRT delivered by WiSE and another system. EBR Systems, the manufacturer of the WiSE CRT System, submitted a Transitional Coverage for Emerging Technologies (TCET) nomination on October 30, 2024, which CMS accepted on January 17, 2025. Subsequently, CMS received a complete, formal NCD request from EBR Systems asking that CMS open an NCA under the TCET pathway. This NCA will focus on the clinical indications for use of WiSE CRT for Medicare beneficiaries. The NCA will analyze clinical evidence for characteristics or comorbidities that make patients more or less likely to benefit from the system, in terms of improved health outcomes such as all-cause mortality and heart failure hospitalizations. CMS is soliciting public comments relevant to the request. We are particularly interested in comments that include scientific evidence, specifically any peer-reviewed literature, that describes the role of WiSE CRT.