WiSE CRT device marks a breakthrough in leadless cardiac pacing
EBR Systems has received FDA approval for its WiSE CRT system, the first and only wireless cardiac pacing device designed for heart failure. The system offers left ventricular pacing without leads and integrates seamlessly with existing right ventricular pacemakers or defibrillators.
Roughly the size of a grain of rice, WiSE is approved for adults who:
- Previously failed or discontinued coronary sinus lead implants, or
- Are considered high-risk for CRT device upgrades.
This approval could expand access to CRT for patients who were previously untreated or considered ineligible.
The system is already compatible with Medtronic’s Micra leadless pacemaker, and testing is underway for use with Abbott’s Aveir.
A limited market launch is planned for 2025, with full commercialization expected in 2026. EBR also plans a five-year post-approval study tracking 320 patients.
“FDA approval of WiSE marks a major step in our journey to commercialize a life-changing solution for patients with few options,” said EBR CEO John McCutcheon.
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