VentriPoint Announces FDA 510(K) Submission for VMS(TM) Heart Analysis System for Pulmonary Arterial Hypertension
VentriPoint Diagnostics (TSX VENTURE:VPT) (OTCQX:VPTDF) announced today that it has submitted to the U.S. Food and Drug Administration (FDA), for 510(k) clearance, the first 2D-ultrasound right-heart analysis system in patients with Pulmonary Arterial Hypertension (PAH). The VMS(TM) heart analysis system will enable physicians to quickly and non-invasively determine the size and function of the right heart - transforming patient care and reducing healthcare costs. Right heart function remains one of the most significant prognostic parameters in PAH.
"This submission marks an important corporate milestone and represents the culmination of several years of dedicated work by VentriPoint and the support of our clinical collaborators at major cardiac centres in the United States, Europe and Canada," commented Dr. George Adams, CEO of VentriPoint. "I would like to thank Dr. Scott Solomon and his team at Harvard Brigham & Women's Hospital for performing the core-lab analysis in the clinical trial, which compared VMS(TM) to conventional cardiac MRI."
The VMS(TM) is approved for clinical use in PAH patients in Canada and Europe and is for investigational use only in the United States.