Cardiac Science gets FDA approval to expand Powerheart trials:
This article was originally published in Clinica
Executive Summary
The US FDA has approved expansion of Phase II clinical trials of Cardiac Science's Powerheart non-surgical automatic external cardioverter defibrillator (AECD). The device is indicated for the hospital bedside, to treat high-risk cardiac patients experiencing ventricular tachyarrhythmias. A 10-patient, single-centre trial of the device was originally approved in June but Cardiac Science submitted an IDE supplement based on data from the first six patients in September and requested a trial expansion. The trial will now include 235 patients at five investigative centres, with the device operating in the fully automatic mode.