Ventripoint Diagnostics has obtained the US Food and Drug Administration (FDA) clearance for its VMS heart analysis system as an adjunct to all existing 2D ultrasound imaging devices to allow computation of the 3D volume and ejection fraction of the right heart in patients with Pulmonary Arterial Hypertension (PAH).
Ventripoint president and CEO Dr. George Adams said the company is pleased to affirm the FDA’s marketing clearance today for the VMS – the first ultrasound method to give accurate right ventricle functional measurements using conventional 2D ultrasound.
"People with PAH require frequent monitoring and adjustments to their treatments, which requires a detailed assessment of right heart function," Dr Adams added.
The VMS heart analysis system is designed to enable physicians to quickly and non-invasively determine the size and function of the right heart – transforming patient care and reducing healthcare costs.
Ventripoint vice-president clinical affairs Jim Bodtke said, "We thank the cardiology teams at The Hospital for Sick Children and Brigham and Women’s Hospital for being the Core Labs on the clinical trial and the Allegheny Hospital, Mayo Clinic, Brigham and Women’s Hospital, Baylor College of Medicine, University of Chicago, and the University Hospital Network (Toronto General Hospital) where the clinical testing was performed for this application."
The VMS is approved for clinical use in PAH patients in Canada and Europe, and now in the US.