EBR Systems launches trial for wireless pacer

EBR Systems said yesterday that it launched a 350-patient investigational device exemption trial of its Wise wireless pacemaker it hopes to use to win FDA approval. Sunnyvale, Calif.-based EBR’s 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. The FDA approved the Solve-CRT study back in September 2016. The randomized, double blinded pivotal trial will compare treatment with the Wise device to a sham procedure in which the device is implanted but not activated in patients who failed to respond to or are otherwise unable to receive conventional cardiac resynchronization therapy, according to ClinicalTrials.gov. The primary safety outcome is freedom from procedure- and device-related complications at six months, including electrode  dislodgement, migration or malfunction; vascular complications from the procedure; transmitter/battery pocket complications; and stroke/transient ischemic attack. Solve-CRT has three primary endpoints, all at six months: mean change in left ventricular end systolic volume; the percentage of subjects with an improvement of greater than 15% in LVESV; and a composite improvement measure using the New York ...
Source: Mass Device - Category: Medical Devices Authors: Tags: Cardiovascular Clinical Trials Cardiac Rhythm Management EBR Systems Inc. Source Type: news