PD2i Cardiac Analyzer
Vicor Technologies medical device, the PD2i Cardiac Analyzer ("Analyzer"), is based on a patented, proprietary algorithm which we believe accurately risk stratifies patients into those who are at high or low risk of suffering a fatal arrhythmic event or Sudden Cardiac Death ("SCD") within a six month time frame. SCD is the leading cause of natural death in the United States each year with 500,000 reported cases. We plan to file for 510(k) device approval based upon the completion of a large-scale clinical trial (VITAL) ("Prospective, Multi-Center Study of the Ability of the PD2i Cardiac Analyzer to Predict Risk of Ventricular TachyArrhythmic Events such as, Sudden Cardiac Death VentricuLar Fibrillation (VF) or Ventricular Tachycardia (VT) in High Risk Patients") which began patient enrollment in November 2006. The trial will be coordinated by the Harvard Clinical Research Institute (a Harvard University affiliate), and Target Health, Inc. (New York, New York).
The PD2i Cardiac Analyzer addresses a significant health care issue which involves a patient cohort of at least 12,000,000 patients. This patient cohort is composed of the MADIT-II (Multicenter Automatic Defibrillator Implantation Trial II)/SCD-HeFT (Sudden Cardiac Death in Heart Failure Trial,) patient population; many of whom may need an Implantable Cardioverter Defibrillator ("ICD") as life saving therapy. However, it has been noted in recent registry studies that over 70% of the implanted ICD’s never have an appropriate firing. We believe this over-implantation has led to a substantial and unnecessary medical cost burden and places patients at risk because of the complications which can accompany this surgery. There is also the risk of not identifying patients who need this life-saving therapy, because current risk stratification criteria do not provide physicians with the ability to accurately risk stratify their patients.
Our Status
The VITAL trial was initiated in August 2006 and is being conducted by the Harvard Clinical Research Institute ("HCRI") which is responsible for the overall coordination and monitoring of the trial. The FDA, in pre-IDE (Investigational Device Exemption) meetings, agreed to the final PD2i protocol and study design for the pivotal VITAL study. Target Health, Inc., a full service contract research organization is responsible for developing the electronic case report form to permit the gathering of patient data via the Internet, and will be responsible for preparing and submitting our Premarket Notification 510(k).
- 700-900 patients (MADIT-II/SCD-HeFT patient cohort)
- 30-60 Sites
- Coordinated by the Harvard Clinical Research Institute (HCRI)
- Director: Dr. Matt Reynolds
- Final protocol has been approved by FDA
- First patient enrolled in November 2006
- 510(k) Submission anticipated in 2009
As of March 31, 2008, 18 sites were enrolling patients and approximately 80 patients had been enrolled to date.