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VentriPoint Diagnostics Ltd. (VPTDF) Pursues European and Canadian Approvals for New Non-Specific Heart Disease Application
Today before the opening bell, VentriPoint Diagnostics announced it has filed for CE Mark and Health Canada approvals for its database for non-specific heart disease (NRV). By using this database, clinicians can 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.
“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.”
Approximately 27 million people in the world population have some form of heart disease. VentriPoint Diagnostics’ NRV database will provide a direct avenue for clinicians to better evaluate and care for these individuals. VentriPoint Diagnostics anticipates receiving a response from the European CE Mark and Health Canada offices in the next 30 days.
The database will be used alongside the VMS-2DE™ heart analysis system for patients where knowledge of the function of the right heart could be used to assess 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 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.
For more information, visit www.ventripoint.com
