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.
The WiSE CRT system is the size of a cooked grain of rice. It received FDA approval in April. Following FDA approval, the company also brought in significant funding to support the system. 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.
Today, EBR says the first patients in the WiSE utilization and performance (WiSE-UP) study were treated at St. Bernards Heart & Vascular Center in Arkansas by Dr. Devi Nair, a globally recognized electrophysiologist. The company says it marks an important step forward in advancing CRT for patients with heart failure and the addition of left ventricular endocardial pacing (LVEP).
EBR says it plans for the sponsored study to follow more than 300 patients across 50 centers over five years. It aims to generate both short- and long-term performance data to inform future clinical practice.
“It was an honor to lead the team performing the first WiSE system implant as part of the WiSE-UP Study,” said Nair. “Our entire team is proud to contribute to this important study, which we believe will further demonstrate the benefits of left ventricular endocardial pacing for patients with heart failure. We look forward to continuing our collaboration with EBR Systems as we work together to advance innovation in cardiac resynchronization therapy and improve patient outcomes.”
