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Tuesday, July 16, 2013 12:05:04 PM
VentriPoint’s Angelo (VMS™) heart analysis system provides a quick and accurate assessment of the right ventricle heart function. Following several installation in multiple sites in cardiac centers in Europe, Canada, and the United States, the company aims to install the device in more centers and expand its applications beyond congenital heart disease in adults and children.
Angelo’s (VMS™) 2D ultrasound imaging provides the accuracy of an MRI but eliminates several disadvantages of traditional imaging, such as a long procedure time, a claustrophobic environment, general anesthesia often needed for children, lengthy heart analysis process, and the need for a second trip to the hospital.
The procedure boasts a brief process time of between 5-10 minutes, including examination and analysis, which eliminates the need for sedation that lengthy MRIs may require. Angelo (VMS™) uses 2D ultrasound equipment, so the process in its entirety can be done on the first visit.
As previously reported, the FDA has requested additional information from the company concerning its 510(k) submission for Pulmonary Arterial Hypertension (PAH). While PAH is relatively rare (affecting 1 in 100,000 to 1 in 1 million people), the disease is life-threatening, worsening over time – approximately 50 percent of people diagnosed with PAH die within five years, according to the American Lung Association. Early detection of the disease followed by proper treatment improves the quality of life and helps the person perform everyday tasks.
Coordinating with the FDA, VPTDF has crafted a statistical plan to obtain and deliver additional information which is currently re-analyzing clinical studies.
The company’s VMS™ technology has been approved for clinical use in Canada and Europe.
For more information, visit www.ventripoint.com
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