The company said the U.S. Centers for Medicare & Medicaid Services (CMS) initiated a NCD to evaluate uniform Medicare coverage for leadless left ventricular (LV) endocardial pacing used in cardiac resynchronization therapy (CRT).
EBR said the initiation of the NCD process represents a significant milestone in establishing uniform coverage for its WiSE system.
The company, which has its U.S. base in Sunnyvale, California, says WiSE is the world’s only wireless cardiac pacing device for heart failure. It designed its WiSE system to significantly expand the population of patients who could benefit from CRT. The leadless solution delivers left ventricular pacing. It works seamlessly with existing pacemakers, defibrillators or CRT devices that provide right ventricular pacing.
WiSE is the size of a cooked grain of rice. It received FDA approval in April 2025. Following FDA approval, the company also brought in significant funding to support the system and enrolled the first patients in a new study of WiSE. EBR says the Medtronic Micra leadless pacemaker qualifies for use with WiSE CRT. Testing remains underway to garner approval for WiSE with the Abbott Aveir leadless pacemaker, too.
EBR says WiSE marks the first technology to enter CMS’ Transitional Coverage for Emerging Technologies (TCET) pathway. It expedites Medicare coverage for FDA-designated breakthrough devices, the company says. CMS offered a projected timeline that would include WiSE NCD approval by early 2027.
According to EBR, a positive NCD decision would expand patient access and support scaled U.S. commercial efforts.
