RECEIVES MARKET CLEARANCE FROM US-FDA FOR COMPLETE HEART ANALYSIS SYSTEM USING 2D ULTRASOUND
Ventripoint Diagnostics Ltd. (VPT.V) has received market clearance from the U.S. Food and Drug Administration to sell its VMSplus 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 VMSplus is the first simple echocardiography system to be approved by the FDA for the 3-D volumetric analysis of all four chambers of the heart using 2-D ultrasound," stated Dr. George Adams, chief executive officer of Ventripoint. "Now we can offer the VMSplus to American physicians so they can accurately and easily evaluate and monitor hearts in children and adults during a routine cardiology appointment."
The USA is the largest medical-device market in the world with more than 40 million cardiac ultrasound exams per year. 2-D ultrasound is the modern stethoscope and is employed worldwide as the first step in evaluating heart disease.
The VMSplus 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 2-D 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 VMSplus, it is now possible to obtain this valuable information quickly, easily and cost effectively.