Today, VentriPoint Diagnostics, developer of ultrasound tools used on patients with heart disease, announced that the European Notified Body, Intertek Semko AB, has granted a CE Mark for its NRV™ application, which pertains to the analysis of 2-D ultrasound images for patients with non-specific heart disease. The application will allow clinicians to rapidly and accurately assess the status of the right ventricle in patients without significant congenital heart defects or pulmonary hypertension, but who may have a variety of other conditions (such as left-heart failure or valve disease).
The NRV™ database can be used in conjunction with the VMS-2DE™ heart analysis system in instances when knowledge of the function of the right heart is useful in assessing overall heart function. The VMS-2DE™ is approved for clinical use in Europe and Canada. In the United States, the system is currently available for investigational use only.
Adding the NRV™ application to the VMS™ heart analysis systems provides a direct avenue for clinicians to better evaluate and care for individuals currently suffering from some form of heart disease. The application may also be used to provide a reference baseline study for patients at risk for developing right-heart dysfunction, who may benefit greatly from frequent monitoring.
“Leading cardiologists, who have the VMS-2DE™ heart analysis system, have been requesting the NRV™ application so they can examine almost every patient they see,” remarked VentriPoint’s CEO, Dr. George Adams. “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.”
VentriPoint also announced that its quality management system has passed the annual surveillance audit and has received renewal compliance certificates for ISO 13485:2003/CMDCAS and MDD 93/42/EEC – Annex II standards. These certificates are required to maintain the company’s licenses to sell medical devices in Europe and Canada.
For more information on VentriPoint and its leading-edge technology, visit www.ventripoint.com
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