Vicor seeks FDA clearance for cardiac marketing claim

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Vicor Technologies has submitted a 510(k) premarket notification to the FDA for its PD2i algorithm and software to secure a claim for identifying, in conjunction with patient medical history and other tests, congestive heart failure patients at elevated risk of cardiac mortality.

The Boca Raton, Fla.-based company develops diagnostics that risk stratify populations for future pathological events including cardiac death and nervous system dysfunction.

This filing is based on findings obtained from  the PD2i (Prognostic Significance of Point Correlation Dimension Algorithm in Chronic Heart Failure) study, which was conducted under a collaborative agreement with the University of Rochester in Rochester, N.Y., 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 (Merte Subita en Insufficiencia Cardiaca) trial, in which the participants were followed for an average period of 44 months.