Ventripoint Diagnostics Ltd. has announced that the U.S. FDA has cleared the VMS™ heart analysis system to be 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).
PAH is the most serious form of the five recognized groups of pulmonary hypertension and is a devastating disease with an average patient lifespan of less than 3 years after diagnosis if untreated. It affects individuals from infancy to the elderly. Although treatment started early after detection appears more effective than when started later, the majority of patients with PAH continue to be diagnosed too late for treatment to be fully effective. With increasing availability of effective therapies, and evidence-based treatment guidelines recommending frequent monitoring, functional tests should prove invaluable for managing patients with PAH.
Right heart function remains one of the most significant prognostic parameters in PAH. Ventripoint Diagnostics says its VMS heart analysis system enables physicians to quickly and non-invasively determine the size and function of the right heart – transforming patient care and reducing healthcare costs.
“We are 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,” said Dr. George Adams, President and CEO of Ventripoint. “People with PAH require frequent monitoring and adjustments to their treatments, which requires a detailed assessment of right heart function.”
“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,” said Jim Bodtke, Vice-President of Clinical Affairs for Ventripoint.
Source: Ventripoint Diagnostics Ltd.