EBR Systems Secures National Coverage Analysis for the WiSE System

The U.S. Centers for Medicare and Medicaid Services (CMS) has initiated a National Coverage Determination (NCD) to evaluate uniform coverage for leadless LV endocardial pacing used in cardiac resynchronization therapy (CRT).

Initiating the NCD process is a key outcome of EBR Systems Inc.’s engagement with CMS through the Transitional Coverage for Emerging Technologies (TCET) pathway and represents a significant milestone in establishing uniform national Medicare coverage for the WiSE System.

Key highlights:

• EBR’s WiSE System is the first technology to enter CMS’s TCET program, underscoring the differentiated clinical significance of leadless left ventricular endocardial pacing, according to the company.
• The TCET program expedites Medicare coverage for U.S. Food and Drug Administration (FDA)-designated Breakthrough Devices, and CMS has formally initiated the NCD process for the WiSE System—a major step toward broad national access for patients.
• CMS’s projected timeline, which would deliver WiSE NCD approval by early next year, is faster than the typical pathway of more than three to five years without TCET.
• A positive NCD decision would establish a uniform Medicare coverage framework, materially expand patient access, and support scaled U.S. commercialization.

EBR was the first company selected for the TCET program by CMS, which began in 2025 after an earlier pilot phase. TCET provides a meaningfully accelerated pathway compared with the typical three- to five-year timeframe for companies pursuing national Medicare coverage. The WiSE System received FDA Breakthrough Device designation and FDA approval, supporting EBR’s progress through TCET toward a national Medicare coverage pathway. A positive NCD outcome would support broader Medicare coverage, expanded patient access, and U.S. commercialization efforts.

The WiSE System received FDA approval in April 2025. CMS granted approval for both the New Technology Add-on Payment (NTAP) program for inpatient procedures and the Transitional Pass-Through (TPT) payment for outpatient procedures, effective Oct. 1, 2025. The ongoing NCD process is intended to establish a national Medicare coverage framework for eligible patients and providers, further supporting access to and adoption of the therapy in the United States.

Under the published timeline, CMS expects the NCD for WiSE to begin in early 2027. Until a national coverage determination takes effect, the WiSE System will continue to be evaluated on an individual basis for coverage of Medicare beneficiaries based on medical necessity.

The WiSE System delivers LV endocardial pacing without a transvenous LV lead using targeted ultrasound. A subcutaneous transmitter and battery detect the RV pacing signal and, within milliseconds, emit ultrasound energy that a rice-sized endocardial electrode converts into an electrical pulse—enabling synchronized biventricular pacing. This LVEP approach is engineered for versatility across patient anatomies and is supported by peer-reviewed outcomes from SOLVE-CRT pivotal trial. WiSE is approved for commercial use in the United States and limited to clinical study use outside of the United States.

EBR Systems is a cardiac rhythm management company helping physicians deliver optimal cardiac pacing for heart failure patients. The WiSE System—the first FDA approved solution for leadless left ventricular endocardial pacing (LVEP) in CRT—combines advanced engineering with peer-reviewed clinical evidence to expand access for patients who previously lacked options and to improve outcomes.