A Diagnostics & Imaging Week
At a recent annual shareholders meeting, Vicor Technologies' (Boca Raton, Florida) president/CEO, David Fater, reviewed strategies and developments to commercialize the company's PD2i Cardiac Analyzer for risk stratification of patients for sudden cardiac death (SCD).
He also discussed the company's collaboration with the U.S. Army to assess severity of injury, and probability of survival, for critically injured combat casualties and critically ill civilian patients.
Fater cited what he termed the "exciting, and rapid, developments with the U.S. Army's Institute of Surgical Research, since signing a Collaborative Research and Development Agreement in January."
He noted that collaborative effort could lead to a 510(k) approval by FDA late this year for use of the PD2i to triage wounded soldiers, which can also be used in both military and civilian applications in the assessment of trauma victims.
The collaboration is expected to lead to the development of new comprehensive decision-support tools and/or devices that may incorporate the PD2i algorithm alone, or in association with other metrics currently under investigation, with the goal of monitoring, assessing status and predicting outcome in critically injured humans.
The CRADA study is titled, "Prediction of Injury Severity and Outcome in the Critically Ill Using the Point Correlation Dimension Algorithm."
Fater discussed with shareholders strategies to position the company to initiate commercialization of the PD2i device for trauma and emergency response later this year, anticipating FDA approval.
He said Vicor also would seek CE-mark approval for the device in the European Union.
Vicor believes the PD2i accurately risk-stratifies patients who are at high or low risk of suffering SCD within a six-month time frame, and who may need an implantable cardioverter defibrillator (ICD).
Fater said the issue of ICD implantation and risk stratification is "extremely important" to the company, offering as support a recent Wall Street Journal article in which a Duke University (Durham, North Carolina) cardiologist described the diagnostic situation for SCD as in "chaos."
Vicor reported in May that the journal Therapeutics and Clinical Risk Management had accepted for publication in its August issue positive results of a clinical study conducted by the company titled "Risk Stratification for Arrhythmic Death in an Emergency Department Cohort: a new method of nonlinear PD2i analysis of the ECG."
The study enrolled 918 patients — 876 of whom completed the study — in six emergency departments. The study achieved a sensitivity of 96% and a specificity of 85% with a negative predictive value of 99%, for the PD2i.
Fater said the study further increased the company's high degree of confidence that the pivotal VITAL trial will be successfully completed and serve as the basis for Vicor to obtain FDA clearance through the 510(k) process.