EBR Systems said today that it has received breakthrough device designation from the FDA for its Wise CRT system for the treatment of heart failure.
Sunnyvale, Calif.-based EBR Systems’ Wise system is a wireless pacer designed to improve the heart’s pumping ability by synchronizing the left and right ventricles to distribute blood to the lungs and body more effectively. It uses a wireless electrode the size of a grain of rice, which is implanted in the left ventricle wall through a minimally invasive procedure, according to the company.
EBR Systems the Wise system offers cardiologists a wider choice of pacing locations, enables patient-specific customization of the pacing site and may improve cardiac resynchronization therapy response.
“This breakthrough device designation underscores the need for novel solutions for heart failure patients, who have few options today,” EBR Systems’ president & CEO John McCutcheon said in a news release. “We are excited that the Wise system has received breakthrough status, which will enhance the review process to bring this important technology to these patients.”
The Wise system is under evaluation in a randomized, double-blinded pivotal trial that is enrolling 350 heart failure patients in the U.S., Europe and Australia who have not responded to or are unable to receive conventional CRT. The study began in January 2018 and has an estimated primary completion date set for this month, with a study completion date estimated for November. EBR Systems added $30 million in a funding round last month, earmarking it for the trial’s enrollment, as well as preparations to launch the system commercially.