Ventripoint Diagnostics has obtained CE mark certification from European notified body Intertek Semko for its NRV application for the VMS-2DE heart analysis system.
The NRV database can be used in conjunction with right heart analysis system where knowledge of the function of the right heart is useful in assessing the overall heart function and optimally treating the patient, claims the company.
With the analysis of 2-D ultrasound images, the application assesses the status of the right ventricle in all patients who do not have significant congenital heart defects or pulmonary hypertension, but may have other conditions such as left-heart failure or valve disease.
The application can also be used to provide a reference baseline study for patients at risk for developing right heart dysfunction and would benefit from frequent monitoring.
Ventripoint Diagnostics CEO Dr George Adams said, "This approval will allow our sales force to offer this major expansion of the capability of the VMS-2DE to our existing and pending customers in Europe, where heart disease remains the leading cause of death at a financial cost of 196 billion Euros each year."
Approved for clinical use in Europe and Canada, the VMS-2DE system is available only for investigational use in the US.
