Ventripoint Files Application for Complete Heart Analysis System With Health Canada
Earlier this month, Ventripoint Diagnostics Ltd. (TSX-V: VPT) announced that it had filed an application with Health Canada for approval of the expansion of the VMS™ heart analysis product to include right atrium (RA), left atrium (LA) and left ventricle (LV) chambers of the heart. The VMS is already licensed in Canada for use for the right ventricle (RV). This expansion allows the determination of volume and function for all four chambers of the heart using conventional 2D ultrasound and reduces the need for costly and delayed MRI exams, which is the only other way to get accurate and reliable measurements.
"I am pleased to report we have successfully built and tested the KBR databases for the RA, LA and LV to yield results substantially equivalent to gold-standard MRI," stated Dr. George Adams, CEO of Ventripoint. "This will enable patients to be fully evaluated using 2D ultrasound on each visit and allow for better monitoring of changes in the anatomy and function of the heart."
Each chamber of the heart is important in understanding how the heart is functioning in the numerous different types of heart disease. For example, it has been shown that changes in LA function are important in predicting outcomes, which are needed to properly perform patient monitoring in ischemic heart disease, heart failure, non-ischemic cardiomyopathies, aortic stenosis, hypertension and atrial fibrillation. The LA size is affected by heart adaptations in a variety of cardiovascular diseases and a strong predictor of cardiovascular severity and death. The complex shape of the RA makes it difficult to calculate volumes accurately even using MRI, where a high heart rate causes clinically-relevant errors. Measurement of left and right atrial size is also important for the management of arrhythmias, valvular and congenital heart disease. The LV is the major pumping chamber of the heart and is associated with all types of heart disease. The importance of the RV in right-heart diseases has been well described and the medical literature is increasingly documenting the need for RV analysis in left heart disease as well.
Health Canada usually approves such applications in 30 to 60 days and the Company will begin marketing the product as soon as it receives the medical device license to do so in Canada.
The Company is preparing submissions for other jurisdictions and will announce when they are submitted.
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