David H. Fater, CEO of Vicor Technologies, Inc. (OTCBB: VCRT), today announced the initial results of a study designed to analyze data from the Merte Subita en Insufficiencia Cardiaca (MUSIC) Trial using its PD2i- algorithm and software. Vicor Technologies is a biotechnology company focused on the development of innovative, non-invasive medical devices using its patented, proprietary PD2i- nonlinear algorithm and software. Vicor develops diagnostics that accurately risk stratify specific target populations for future pathological events including cardiac death and autonomic nervous system dysfunction, and trauma victims in need of lifesaving intervention.
The study, titled "Prognostic Significance of Point Correlation Dimension Algorithm (PD2i) in Chronic Heart Failure," was conducted under a collaborative agreement with the University of Rochester and the Catalan Institute of Cardiovascular Sciences in Barcelona. The goal of the study was to evaluate the ability of Vicor's PD2i- nonlinear algorithm to predict cardiac events in the 537 chronic heart failure patients enrolled in the MUSIC Trial; MUSIC Trial participants were followed for an average period of 44 months. The conclusion of the University of Rochester researchers who conducted the study is that the PD2i- nonlinear algorithm and software is predictive of total mortality, cardiac death, and heart failure death in patients with left ventricular ejection fraction of less than or equal to 35%. With a P value of 0.004 the study results are highly statistically significant.
Commenting on the study and its results, Wojciech Zareba, M.D. Ph.D. the Principal Investigator at the University of Rochester said, "These results are of major importance for risk stratifying heart failure patients who are eligible for therapy with an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy with defibrillator (CRT-D). Currently, only about 30-40% of heart failure patients eligible for this therapy receive devices. Testing heart failure patients using the PD2i- should enhance risk stratification and motivate physicians to implant these devices in ICD/CRT-D eligible patients with abnormal PD2i- test results."
"We're extremely pleased with the results achieved in this study. Researchers from the University of Rochester and Vicor scientists are studying these initial results to determine whether the resulting data will support a 510(k) submission to the Food and Drug Administration (FDA) for a marketing claim. What we have achieved may broaden the market for the PD2i Analyzer- as a diagnostic that will significantly contribute to cardiologists in their assessment of treatment options for heart failure patients," stated Mr. Fater.
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