Ventripoint Receives FDA Clearance for Heart Analysis System Using 2D Ultrasound

Ventripoint Diagnostics Ltd. has received market clearance from the U.S. Food and Drug Administration (FDA) to sell its VMS+ machine with the four-chamber heart analysis system in the United States. The intended use is for the analysis of ejection fraction (function) and volumes of any chamber of the heart, where they are warranted or desired.
 
”The VMS+ is the first simple echocardiography system to be approved by the FDA for the 3D volumetric analysis of all four chambers of the heart using 2D ultrasound,” stated Dr. George Adams, CEO of Ventripoint. “Now we can offer the VMS+ to American physicians so they can accurately and easily evaluate and monitor hearts in children and adults during a routine cardiology appointment.”
 
The United States is the largest medical device market in the world with over 40 million cardiac ultrasound exams per year. 2D ultrasound is the modern stethoscope and is employed worldwide as the first step in evaluating heart disease.
 
The VMS+ product allows for the determination of heart function, expressed as ejection fraction or volumes of any of the four chambers of the heart using conventional 2D ultrasound.  These measurements are increasingly recognized as critically important in monitoring the heart and predicting outcomes of patients. This applies to patients with heart failure, abnormal heart rhythms, congenital heart disease, pulmonary hypertension and hypertension. With the VMS+, it is now possible to obtain this valuable information quickly, easily and cost effectively.
 
Ventripoint’s medical technology produces critical heart information by processing standard information received from existing medical imaging equipment with patented and proprietary methods incorporating Knowledge Based Reconstruction (KBR) algorithms and proprietary cardiac databases (sometimes called catalogues). The company’s KBR method allows for the creation of a three-dimensional model of all the chambers of the heart, right and left ventricles and right and left atria, using images generated from existing 2D and 4D imaging equipment (real time 3D imaging is now considered to be 4D with time as the fourth dimension). The company’s technology platform is applicable to all heart diseases.
 
Ventripoint Diagnostics Ltd., headquartered in Toronto, Canada, develops and commercializes diagnostic tools to monitor patients with heart disease—a major cause of death in developed countries and a rapidly rising incidence in emerging countries.  

The Ventripoint Medical System (VMS) is the first cost-effective and accurate tool for measuring the function of all four chambers of the heart, and is the only approved way to generate substantially equivalent results to the gold-standard MRI for right ventricular volumes using 2D echocardiography. Approximately 50 percent of patients with heart failure have dysfunctional right hearts which go undetected and untreated, leading to repeat hospitalizations. The VMS is designed to reduce healthcare costs while improving quality of life in patients with heart disease.