Ventripoint’s VMS Systems Wins Expanded FDA Indication

Ventripoint Diagnostics Ltd.’s VMS heart analysis system has been granted expanded U.S. Food and Drug Administration indication for right ventricle volume and ejection fraction assessment, company executives said.

Previously, the system was limited for use on pulmonary arterial hypertension patients, diagnosed in rougly 200,000 Americans annually. An RV diagnostic can be an important predictive tool for heart disease and enable cardiologists to decide when to evaluate a patient.

The device is the only one available that provides as accurate results as an MRI, Ventripoint officials claim. Magnetic resonance imaging (MRI) takes hours while a computed tomography scan involves high doses of radiation, and both methods may be unusable in patients with kidney issues.

“This change in use criteria means physicians in the U.S.A. can now use the VMS on patients that they believe will benefit from assessment of RV function, without being limited to a specific condition,” said Jim Bodtke, vice president of 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.”

Based in Bellevue, Wash., Ventripoint develops and commercializes diagnostic tools to monitor patients with heart disease.