The study enrolled 918 patients (876 of which completed the study) in six emergency departments. The study achieved a sensitivity of 96% and a specificity of 85% with a negative predictive value of 99%.
The PD2i Cardiac Analyzer contains the patented PD2i algorithm which provides a method for evaluating electrophysiological potentials with a high sensitivity and high specificity used to predict future pathological events that is fatal cardiac arrhythmias. The PD2i algorithm detects deterministic, low-dimensional excursions in nonstationary heartbeat intervals.
David Fater, Vicor’s president and CEO, said: “We are delighted that we continue to demonstrate, through our clinical efforts, the ability of our proprietary PD2i Analyzer to accurately risk stratify patients into those who require Implantable Cardioverter Defibrillation (ICD) intervention and those who do not.”