European notified body Intertek Semko has granted CE mark certification to Ventripoint Diagnostics’ NRV application for analysis of 2-D ultrasound images for patients with non-specific heart disease.
The NRV application can be used in conjunction with the VMS-2DE 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.
The application allows clinicians to assess the status of the right ventricle in all patients that do not have significant congenital heart defects or pulmonary hypertension, but may have other conditions such as left-heart failure or valve disease.
In addition, the application can be used to provide a reference baseline study for patients at risk of developing right heart dysfunction and would benefit from frequent monitoring.
Ventripoint Diagnostics CEO Dr George Adams said cardiologists have been requesting the NRV application so they can examine almost every patient they see.
"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 €196bn each year," Adams added.
The VMS-2DE system, which is approved for clinical use in Europe and Canada, is available for investigational use only in the US.