The FDA granted EBR Systems an investigational device exemption to begin a clinical trial to evaluate the company’s wireless cardiac pacing system for patients with heart failure.
EBR Systems plans on starting the prospective, randomized study in mid-2017. The company expects to enroll 350 patients who failed conventional cardiac resynchronization therapy (CRT) or were previously unable to be treated with conventional CRT systems.
The wireless, endocardial cardiac pacing system incorporates EBR Systems’s Wise (Wireless Stimulation Endocardially) technology for CRT and stimulates the heart’s left ventricle. The technology is already approved in Europe.
Vivek Reddy, MD, a cardiologist and professor at Mt. Sinai Hospital in New York, presented results of EBR Systems’ SELECT-LV study in May at the Heart Rhythm Society scientific sessions in San Francisco. The study found that 34 of 35 patients who had failed conventional CRT therapy were implanted successfully with WiSE technology. In addition, 85 percent of patients improved their clinical composite score at six months.
EBR Systems said the WiSE technology could potentially benefit 1.5 million patients worldwide.
“Patients who have failed conventional CRT continue to deteriorate from their heart failure and are repeatedly subjected to costly hospitalizations,” William Abraham, MD, director of Ohio State University’s Wexner Medical Center and member of the study’s steering committee, said in a news release. “We have actively sought new treatment alternatives for this large and growing patient population. WiSE is easily the most promising solution to this costly problem. Its tiny receiver makes endocardial, left ventricular pacing possible for the first time. There is nothing like it in cardiology.”