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FDA grants Ventripoint marketing clearance for expanded indications of its VMS system

Last updated: 23:21 25 May 2015 AEST, First published: 04:21 26 May 2015 AEST

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Details about the RV function, can help cardiologist predict the course of heart disease, determining the frequency of evaluation that a patient requires

Shares of VentriPoint Diagnostics (CVE:VPT) soared above 18% on Monday afternoon as the US Food and Drug Administration (FDA) approved additional indications of its VMS Heart Analysis system.

The medical device company’s VMS is a heart imaging system that offers a faster and more convenient alternative to an MRI procedure. It can capture usable images of the right side of the heart, a typical challenge in the industry due to its proximity to the ribs, posing a particularly poor vantage for image capture.

According to Ventripoint, right heart function remains one of the most significant prognostic parameters for all heart disease.

“The VMS system is indicated for use where RV (right ventricle) volumes and ejection fractions are warranted or desired,’’ said the Ventripoint in a statement. Details about the RV function, can help cardiologist predict the course of heart disease, determining the frequency of evaluation that a patient requires.

The expanded FDA approved indications mean that “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," according to Ventripoint’s Vice-President, Clinical Affairs and Development, Jim Bodtke.

Until now, the VMS had been available only for use on adults with known pulmonary arterial hypertension, which is newly diagnosed in approximately 200,000 individuals each year in the United States. The new indications mean that “the VMS can be used on the more than 20 million people that suffer from heart disease”, said the company.

In March 2014, the company was granted FDA approval for its heart diagnostic system for right ventricle assessment in adult patients with pulmonary arterial hypertension (PAH). The system is also approved in Canada and Europe, with the company now working to further expand the system's applications.

A German study from 2014 showed that the time to complete the analysis using VMS was reduced to just five minutes, compared to between 10 to 30 minutes using conventional techniques.

Ventripoint recently has a focused marketing strategy that will include securing distribution partners for the VMS product in the U.S., signing up additional marketing partners in Europe and the Middle East, and furthering discussions with ultrasound manufacturers for collaborations on technology integration. 

VentriPoint Diagnostics gets gateway CE mark

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on 11/1/18