EBR’s Wireless CRT Faces Market Test as Reimbursement and Adoption Loom
EBR Systems has completed the first commercial US implants of its FDA-approved WiSE wireless cardiac resynchronization therapy system, marking a pivotal step toward broader market adoption and reimbursement.
- First US commercial implants of WiSE CRT System completed
- Early procedures at leading US medical centers highlight clinical importance
- Reimbursement add-on payments expected to start October 2025
- Limited market release planned targeting key institutions
- WiSE technology offers leadless left ventricular pacing for heart failure patients
A Milestone in Cardiac Care
EBR Systems, the Silicon Valley-based medical device innovator, has announced a significant commercial breakthrough with the first US implants of its WiSE cardiac resynchronization therapy (CRT) system. This wireless, leadless technology, recently approved by the FDA, represents a novel approach to treating heart failure patients who require precise left ventricular pacing.
The initial implantations took place at prestigious institutions including St. David's Medical Centre and the Cleveland Clinic. These early cases underscore the system’s clinical relevance, particularly for patients who previously had limited or no options due to non-functional coronary sinus leads or pacing-induced heart failure.
Clinical and Market Significance
Unlike traditional CRT devices that rely on leads threaded through the coronary sinus, the WiSE system delivers pacing endocardially; inside the heart; without wires. This method aligns more closely with the heart’s natural activation pattern, potentially improving patient outcomes and reducing complications associated with leads.
EBR Systems is preparing for a limited market release (LMR) starting in October 2025, coinciding with the anticipated commencement of reimbursement add-on payments for both inpatient and outpatient procedures. This phased rollout will focus on high-volume and strategically important medical centers to build clinician advocacy and accelerate adoption.
Voices from the Frontline
Leading cardiologists involved in the pilot release expressed optimism. Dr. Robert Canby of St. David's Medical Centre highlighted the transformative potential of leadless left ventricular pacing for patients who had exhausted other options. Meanwhile, Dr. Niraj Varma from the Cleveland Clinic emphasized the physiological advantages of endocardial pacing and its promise for improved resynchronization.
EBR’s CEO John McCutcheon reflected on the milestone with pride, noting the company’s commitment to advancing cardiac rhythm management through innovative wireless technology.
Looking Ahead
While the initial commercial implants mark a crucial step, the broader market adoption of WiSE will depend on clinician acceptance, reimbursement pathways, and ongoing clinical outcomes. The upcoming limited market release and reimbursement milestones will be key indicators of the system’s commercial trajectory.
Bottom Line?
EBR Systems’ WiSE CRT system is poised to reshape heart failure treatment as it moves from pilot implants to wider clinical adoption and reimbursement.
Questions in the middle?
- How quickly will reimbursement add-on payments translate into broader commercial uptake?
- What clinical data will emerge from the limited market release to support long-term efficacy?
- Could WiSE technology expand beyond CRT to other cardiac or non-cardiac indications?
