FDA clears biphasic external defibrillator:
This article was originally published in Clinica
Executive Summary
The US FDA has cleared Zoll Medicals' external defibrillator, which uses the company's biphasic waveform technology, to treat both ventricular and atrial fibrillation (VF and AF). The device, claimed to be the first external biphasic defibrillator to win US clearance for both VF and AF, has a 68% first-shock efficacy in AF patients compared with only 21% for conventional monophasic technology, said the Burlington, Massachusetts-based company. In a study of VF patients, the biphasic waveform device converted 99% of them on the first shock compared with 93% converted with conventional waveform.