The FDA approved its WiSE cardiac resynchronization therapy (CRT) system through the premarket process. Australia-based EBR Systems — which has its U.S. base in Sunnyvale, California — says WiSE is the world’s only wireless cardiac pacing device for heart failure.
EBR designed its WiSE system to significantly expand the population of patients who could benefit from CRT. The leadless solution delivers left ventricular pacing, working seamlessly with existing pacemakers, defibrillators or CRT devices that provide right ventricular pacing.
The WiSE CRT system is the size of a cooked grain of rice.
FDA approval covers adults (at least 22 years of age) indicated for CRT. These patients have an existing implanted right ventricular pacing system and fall into one of two categories. First, patients may have previously had unsuccessful coronary sinus lead implantation or had their implanted lead turned off (known as previously untreatable). The other group had previously implanted pacemakers or defibrillators but have relative contraindications for CS lead or CRT device implantation (high-risk upgrades).
EBR says the Medtronic Micra leadless pacemaker qualifies for use with WiSE CRT. It currently has testing underway to get the Abbott Aveir leadless pacemaker approved for use with WiSE, too.
The company plans for a limited market release this year, followed by a full rollout in 2026. It also plans to conduct a post-approval study of 320 patients, followed out to five years.
“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,” said John McCutcheon, EBR Systems’ president and CEO. “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.”
