EBR Systems wins FDA nod for wireless pacer trial

EBR Systems said today it won an investigational device exemption from the FDA for a clinical trial of its WiSE wireless cardiac resynchronization therapy device. The Sunnyvale, Calif.-based company claimed the device as the world’s only wireless, endocardial pacing system for stimulating the left ventricle. “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 [cardiac resynchronization therapy] implants and could dramatically improve success rates for heart failure patients around the globe,” principal investigator Dr. Jagmeet Singh, of Boston’s Mass. General Hospital, said in prepared remarks. The EBR device uses a subcutaneous generator to wirelessly deliver ultrasound energy to a “pellet” implanted 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, EBR 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 ...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Clinical Trials Food & Drug Administration (FDA) Regulatory/Compliance EBR Systems Inc. Source Type: news