VentriPoint Diagnostics has received CE Mark approval for its database for non-specific heart disease (NRV). The new approval extends the use of the NRV database for use in assessment of right ventricle (RV) function in all patients. This now includes those who 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.
VentriPoint’s VMS™ is a diagnostic ultrasound tool to monitor patients with heart disease. The company says VMS is the first cost-effective and accurate diagnostic tool for measuring right ventricle heart function.
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.
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.
“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 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.
Source: VentriPoint Diagnostics Ltd.