VentiPoint buoyed by early data from PAH study
The final results of a pilot study undertaken at the University of Chicago, using VentriPoint Diagnostics' VMS diagnostic tool for the treatment of pulmonary arterial hypertension (PAH), have shown a non-statistical average difference between VMS and cardiac MRI (CMR) of 0.65 per cent for volumes from 75mL (normal hearts) to 425mL (dilated hearts), with 95 per cent confidence limits of +/- 3 per cent. There was a link between the two techniques over the entire volume range with correlation coefficients of r2=0.97 for both when the heart was filled with blood (end-diastolic volume) and when it was finished ejecting blood (end-systolic volume).
VMS is described by VentriPoint as the first cost-effective and accurate diagnostic tool for measuring right ventricle heart function. Congenital heart disease in children is the first application in a suite of applications for all major heart diseases including pulmonary hypertension, cardiovascular disease and heart failure. Canada and Europe have granted approval for the sale of the diagnostic tool for pulmonary arterial hypertension and the congenital heart disease, TOF, and is pursuing FDA clearance through the 510(k) process.