SEATTLE, WASHINGTON--(Marketwire - March 21, 2013) - VentriPoint Diagnostics (TSX VENTURE:VPT)(OTCQX:VPTDF) is announcing it has filed for CE Mark and Health Canada approvals for its database for non-specific heart disease (NRV). The NRV database allows clinicians to rapidly and accurately assess the status of the right ventricle (RV) in all patients that do not have significant congenital heart defects or Pulmonary Arterial Hypertension (PAH), yet may have a variety of other conditions, such as left-heart failure or valve disease. It is estimated that 27 million people have some form of heart disease and the addition of this database to the VMS™ heart analysis system will provide a direct avenue for clinicians to better evaluate and care for these individuals.
"Our customers have asked for the NRV application so they can assess the RV in virtually every patient they see," said Dr. George Adams, CEO of VentriPoint. "RV assessments are important in all heart patients and we are proud to offer this cost-effective extension to our VMS™ products."
The NRV database will be used with the VMS-2DE™ heart analysis system for patients where knowledge of the function of the right heart would be useful in assessing the overall heart function to optimally treat the patient. It can also be used to provide a reference baseline study for patients who are at risk for developing right heart dysfunction and would benefit from regular monitoring. Medical research has shown an accurate understanding of the right heart function greatly informs the physician of both right and left heart failure, but it has been hard to obtain this information in a rapid and cost-effective manner until now.
The Company expects to have a response from the European CE Mark and Health Canada offices in the next 30 days.
The VMS-2DE™ is approved for clinical use in Tetralogy of Fallot, dextro-Transposition of the Great Arteries (d-TGA) and PAH in Canada and Europe and is for investigational use only in the United States.
About VentriPoint Diagnostics Ltd.
VentriPoint has created a diagnostic ultrasound tool to monitor patients with heart disease, a leading cause of death in developed countries. VMS™ is the first cost-effective and accurate diagnostic tool for measuring right ventricle heart function. Congenital heart disease in children and adults and Pulmonary Arterial Hypertension are the first applications in a suite of applications for all major heart diseases including cardiovascular disease and heart failure - a multi-billion dollar market potential. Canada and Europe (CE Mark) have granted approval for the sale of its VMS™ tool and the Company is pursuing the US-FDA marketing clearance through the 510(k) process.
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