CMS Initiates National Coverage Determination for WiSE

• CMS initiates NCD process for WiSE System
• First technology in CMS's TCET program
• Potential for broad national Medicare coverage by early 2027
• FDA Breakthrough Device designation supports progress

EBR Systems, Inc. announced that the U.S. Centers for Medicare & Medicaid Services (CMS) has initiated the National Coverage Determination (NCD) process for its WiSE System, a leadless left ventricular endocardial pacing device for cardiac resynchronization therapy. This marks the first technology to enter CMS's Transitional Coverage for Emerging Technologies (TCET) program, which expedites national Medicare coverage for FDA designated Breakthrough Devices. A positive NCD decision would establish a uniform national Medicare coverage framework, significantly expanding patient access and supporting accelerated U.S. commercialization for EBR. The WiSE System received U.S. FDA Breakthrough Device designation and approval, and CMS has granted both the New Technology Add-on Payment (NTAP) and the Transitional Pass-Through (TPT) payment for the device.

WiSE System projected to gain Medicare coverage by early 2027

Positive NCD decision expected to expand patient access and accelerate U.S. commercialization for EBR.