Vicor Submits 510(k) Application for Cardiac Marketing Claim
July 7, 2010 – Vicor Technologies Inc. recently announced that it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for its PD2i algorithm and software. This would secure a claim for identifying, in conjunction with patient medical history and other tests, congestive heart failure patients at elevated risk of cardiac mortality.
Vicor is a biotechnology company focused on the development of 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.
This filing is based on findings obtained from “Prognostic Significance of Point Correlation Dimension Algorithm (PD2i) in Chronic Heart Failure,” a study 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 537 chronic heart failure patients. The researchers concluded 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 percent.
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