VentriPoint Diagnostics Wins FDA Approval For VMS Heart Imaging System
3/10/2014 8:34:15 AM
FDA Clears Ventripoint VMS(TM) Heart Analysis System for Use in Patients with Pulmonary Arterial Hypertension
SEATTLE, WASHINGTON, Mar 10, 2014 (Marketwired via COMTEX) -- Ventripoint Diagnostics Ltd. ("Ventripoint") CA:VPT +25.00% announces that the US Food and Drug Administration (FDA) has cleared the VMS(TM) heart analysis system to be an adjunct to all existing 2D ultrasound imaging devices to allow computation of the 3D volume and ejection fraction of the right heart in patients with Pulmonary Arterial Hypertension (PAH).
"We are pleased to affirm the FDA's marketing clearance today for the VMS - the first ultrasound method to give accurate right ventricle functional measurements using conventional 2D ultrasound," said Dr. George Adams, President and CEO of Ventripoint. "People with PAH require frequent monitoring and adjustments to their treatments, which requires a detailed assessment of right heart function."
Right heart function remains one of the most significant prognostic parameters in PAH. The VMS heart analysis system enables physicians to quickly and non-invasively determine the size and function of the right heart - transforming patient care and reducing healthcare costs.
"We thank the cardiology teams at The Hospital for Sick Children and Brigham and Women's Hospital for being the Core Labs on the clinical trial and the Allegheny Hospital, Mayo Clinic, Brigham and Women's Hospital, Baylor College of Medicine, University of Chicago, and the University Hospital Network (Toronto General Hospital) where the clinical testing was performed for this application," said Jim Bodtke, Vice-President of Clinical Affairs for Ventripoint.
PAH can occur for no known reason but will typically occur in association with many common conditions such as chronic liver disease and liver cirrhosis; connective tissue disorders such as scleroderma or systemic lupus erythematosus (lupus); congenital heart disease (even if repaired) and HIV. PAH is the most serious form of the five recognized groups of pulmonary hypertension and is a devastating disease with an average patient lifespan of less than 3 years after diagnosis if untreated. It affects individuals from infancy to the elderly. Although treatment started early after detection appears more effective than when started later, the majority of patients with PAH continue to be diagnosed too late for treatment to be fully effective. With increasing availability of effective therapies, and evidence-based treatment guidelines recommending frequent monitoring, functional tests should prove invaluable for managing patients with PAH.
The VMS(TM) is approved for clinical use in PAH patients in Canada and Europe, and now in the United States.
About Ventripoint Diagnostics Ltd.
Ventripoint has created tools to monitor patients with heart disease, a leading cause of death in developed countries. VMS(TM) 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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FORWARD-LOOKING STATEMENTS: The statements made in this news release that are not historical facts may contain forward-looking information that involves risk and uncertainties. All statements, other than statements of historical facts, which address Ventripoint's expectations, should be considered forward-looking statements. Such statements are based on management's exercise of business judgment as well as assumptions made by and information currently available to management. When used in this document, the words "may", "will", "anticipate", "believe", "estimate", "expect", "intend" and words of similar import, are intended to identify any forward-looking statements. You should not place undue reliance on these forward-looking statements. These statements reflect a current view of future events and are subject to certain risks and uncertainties as contained in the Corporation's filings with Canadian securities regulatory authorities. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results could differ materially from those anticipated in these forward-looking statements. A description of assumptions used to develop such forward-looking information and a description of risk factors that may cause actual results to differ materially from forward-looking information can be found in Ventripoint's disclosure documents on the SEDAR website at www.sedar.com . The Corporation undertakes no obligation, and does not intend, to update, revise or otherwise publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of any unanticipated events. Although management believes that expectations are based on reasonable assumptions, no assurance can be given that these expectations will materialize.
Ventripoint Diagnostics Ltd.
Dr. George Adams
SOURCE: Ventripoint Diagnostics Ltd.
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