Vicor Technologies, a provider of non-invasive medical devices, has submitted a 510(k) premarket notification to the FDA for its PD2i analyzer 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 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 the 537 chronic heart failure patients enrolled in the Merte Subita en Insufficiencia Cardiaca (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%.
David Fater, CEO of Vicor Technologies, said: “This filing brings us one step closer to being able to market our PD2i algorithm and software to cardiologists, thus enabling them to more effectively identify their congestive heart failure patients at elevated risk of cardiac mortality.”
Vicor Technologies using its patented, proprietary PD2i nonlinear algorithm and software, 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.