EBR Systems wins FDA nod for wireless pacer trial

EBR Systems said today it won FDA investigational device exemption to initiate a trial of its WiSE wireless cardiac resynchronization therapy device.

The Sunnyvale, Calif.-based company touted its device as the world’s only wireless, endocardial pacing system for stimulating the left ventricle, and said with the approval it will initiate a trial as it seeks approval from the FDA.

“WiSE is unique, significant technology that’s cleared for use in Europe and has proven very beneficial thus far. This important medical advance addresses major shortcomings in current CRT implants and could dramatically improve success rates for heart failure patients around the globe,” study principal investigator Dr. Jagmeet Singh of the Harvard Medical School at Massachusetts General Hospital said in prepared remarks.

The EBR device uses a subcutaneous generator to wirelessly deliver ultrasound energy to a “pellet” implanted on the inside of the heart, in the right ventricle, which it uses to synchronize the left and right ventricles. The system is designed to eliminate the need for a left ventricular lead by allowing the operating physician to place the stimulation “pellet” in a patient specific location inside the left ventricle, the company said.

“Patients who have failed conventional CRT continue to deteriorate from their heart failure and are repeatedly subjected to costly hospitalizations. 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,” Dr. William Abraham of Ohio State University

Last October, EBR Systems said it won CE Mark approval in the European Union for its WiSE wireless endocardial cardiac resynchronization therapy device.

The approval came based on a feasibility study of the “wireless” pacemaker, presented last May, which confirmed the device’s safety and pointed the way toward further research.

The 39-patient Select-LV trial consisted of patients who either could not undergo traditional cardiac resynchronization therapy or failed to respond to it, Dr. Vivek Reddy of New York’s Mt. Sinai School of Medicine said.

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