Ventripoint Receives Marketing Clearance from the FDA to Expand the Use of
the VMS Heart Analysis System
Seattle, Washington, May 25, 2015 – Ventripoint Diagnostics Ltd. ("Ventripoint") (TSXV:VPT) is pleased to announce that it has received Marketing Clearance from the U.S. Food & Drug Administration (“FDA”) for the expanded Indications for Use of its VMS™ product which states; “The VMS system is indicated for use where RV (right ventricle) volumes and ejection fractions are warranted or desired”.
“This change in use criteria means physicians in the U.S. can now use the VMS on patients that they believe will benefit from assessment of RV function, without being limited to a specific condition”, stated Jim Bodtke, Vice-President, Clinical Affairs and Development for Ventripoint. “Accurate RV volume assessment is the key to the full understanding or treatment of many heart conditions, and the VMS is the only method on the market that provides results that are widely considered as accurate as the gold standard, MRI.”
Previously the VMS was limited in use on adults with known pulmonary arterial hypertension (PAH), which is newly diagnosed in approximately 200,000 individuals each year in the U.S. Now the VMS can be used on the more than 20,000,000 people that suffer from heart disease.
The information about the function of the RV is known to predict the course of heart disease and can be used by the cardiologist to determine how frequently to evaluate the patient. Heart disease remains the leading cause of death globally with the RV being the determining factor for the vast majority of patient outcomes. The only comparable method used with cardiac ultrasound to assess RV function is real-time 3D echocardiography, which is widely accepted as being inaccurate in terms of volumetric data. Other methods of obtaining functional RV data are inconvenient and can take hours (MRI) or involve high doses of radiation (CT scan). Further, both MRI and CT scan may require the injection of contrast media, which can be detrimental in patients with concerns for kidney failure. The use of VMS overcomes all of the concerns related to MRI and CT, from the most widely used method in the world for heart evaluation, that being 2D Echo. This remains the exam modality of choice as it is convenient, inexpensive, and fast, all of which are benefits gained when using the VMS.
About Ventripoint Diagnostics Ltd.
Ventripoint has created tools to monitor patients with heart disease, a leading cause of death in developed countries. VMS™ is the first cost-effective and accurate tool for measuring right ventricle heart function. The Corporation has a suite of applications for all major heart diseases and imaging modalities including congenital heart disease, left or right heart failure and normal hearts - a multi-billion dollar market potential.
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