FDA approves leadless CRT device for heart failure
EBR Systems, a California-based medtech company, has gained U.S. Food and Drug Administration (FDA) approval for its innovative wireless pacing device for heart failure, the WiSE cardiac resynchronization therapy (CRT) system. The device works with a patient’s existing implant to provide biventricular pacing.
The WiSE CRT system, designed specifically for patients who are not suitable for lead-based pacing devices, is the size of a single cooked grain of rice. It offers left ventricular pacing and can communicate with existing pacemakers, defibrillators and CRT systems that deliver right ventricular pacing. It works with Medtronic’s Micra leadless pacemaker, for instance, while testing is still underway to confirm its compatibility with Abbott’s Aveir leadless pacemaker.
The FDA’s approval covers adult patients 22 years old and older who already have an implanted right ventricular pacing system and are not an optimal candidate for standard CRT therapy.
It is not recommended for patients who are unable to tolerate procedural anticoagulation or contrast agents.
The EBR Systems WiSE leadless cardiac resynchronization therapy (CRT) system.
“We are thrilled to announce this major milestone for EBR and to share this achievement with our dedicated team, shareholders, partners and stakeholders who have supported us on this journey,” John McCutcheon, president and CEO of EBR Systems, said in a statement. “Securing FDA approval for the WiSE CRT System is a transformative moment, marking our transition from clinical development to commercialization. With FDA approval in hand, EBR is well-positioned to bring our innovative solution to market, delivering real impact to patients and servicing a significant unmet need. We look forward to executing our commercial strategy and achieving our first revenue in late 2025, paving the way for sustained growth and long-term success.”
According to the company’s announcement, EBR Systems plans on starting a full-scale release of the WiSE CRT system in early 2026.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.