Vicor Technologies Inc, announces that it has received FDA 510(k) approval (K082709) to market its PD2i Analyzer, permitting immediate commercialization of the technology.
Vicor is a development-stage biotechnology company focused on the commercialization of innovative non-invasive diagnostics using its patented, proprietary PD2i algorithm for cardiovascular and trauma use.
The PD2i Analyzer uses Vicor’s patented, proprietary point correlation dimension algorithm (PD2i), a deterministic, non-linear measure that analyzes ECG data to risk stratify target populations as to future life threatening or fatal events. Specifically, the PD2i Analyzer provides physicians with insight into heart rate complexity over time.
According to David H Fater, President and CEO of Vicor Technologies, "FDA 510(k) approval to commercialize the PD2i Analyzer is a milestone for Vicor. The intended use of the Vicor PD2i Analyzer is to display and analyze electrocardiographic information and to measure heart rate complexity. The clinical significance of heart rate variability, and other parameters, must be determined by the physician."
Vicor has developed a private-label PD2i Analyzer ECG with an original equipment manufacturer (OEM). During the first quarter of 2009, Vicor plans to launch the PD2i Analyzer ECG to its National Cardiac Panel of several hundred cardiologists and have it marketed for general use to other physicians by the OEM.
Fater continued, "Marketing approval from the FDA represents a major step in our strategic marketing plan as the commercialization of the PD2i Analyzer paves the way for expansion of our technology platform, first through the anticipated approval of our triage diagnostic, the PD2i VS, and then for the PD2i CA for risk stratification of sudden cardiac death, both of which are currently in the regulatory process."
Vicor’s PD2i VS, which can identify those in need of immediate life saving intervention (LSI), is poised to help revolutionize trauma triage in both combat and civilian arenas. The PD2i VS is currently in clinical trials under a collaborative effort with the US Army Institute for Surgical Research. Vicor anticipates 510(k) clearance for this product in 2009.
Vicor’s PD2i CA is an accurate, easy-to-use tool for identifying patients at high risk of sudden cardiac death (SCD) and who would benefit from an implantable cardioverter defibrillator (ICD). With more than 500,000 deaths yearly, SCD is the leading cause of death in the United States. There is currently no technology that accurately identifies patients at risk of sudden cardiac death. The PD2i CA is the subject of the VITAL trial, a multi-site, multi-year study being conducted by the Harvard Clinical Research Institute. Vicor expects 510(k) clearance for the Cardiac Analyzer by early 2010.
Vicor Technologies is a development-stage biotechnology company creating innovative non-invasive diagnostics employing its patented, proprietary point correlation dimension algorithm (PD2i.) The PD2i is a deterministic, non-linear measure that analyzes electrophysiological potentials to predict future pathological events with a high degree of accuracy in target populations.