Arizona-based SynCardia Systems revealed that two of its Humanitarian Use Device (HUD) designations for the new 50cc Total Artificial Heart to be used for destination therapy and pediatric bridge to transplant has been approved by the US Food and Drug Administration.
The company added that the 50cc device is a smaller version of its 70cc SynCardia temporary Total Artificial Heart which had been approved by the FDA back in 2004.
Diet, Lifestyle and Heart Disease
The correlation between diet, lifestyle and heart disease. The importance of balanced diet life style and exercise for controlling heart disease.
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The FDA approved HUD designation of the 50cc Total Artificial Heart for destination therapy on January 15 and is available for patients who are at a risk of imminent death from non-reversible biventricular heart failure while its use in treating biventricular heart failure in pediatric patients was approved on January 30.
"The 50cc Total Artificial Heart is designed to fit patients of smaller stature, including many women and adolescents who are too small to receive the 70cc Total Artificial Heart. We are pleased that the FDA recognized the needs of these underserved patient populations and was swift in approving the HUD designations. Together, the 70cc and 50cc Total Artificial Hearts will fit almost all adult men and women, and many adolescents, including patients with congenital conditions", SynCardia CEO and President, Michael Garippa said.
Source: Medindia
Source: Medindia
Congestive Heart Failure
Congestive heart failure (CHF) is a condition in which the heart fails to work adequately as a pump that can deliver oxygen rich blood to the body.
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 Congenital Heart DiseaseHeart diseases that are present at birth are called " Congenital heart diseases". | Advertisement
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Heart Attack
Heart attack is the death of the heart muscle due to loss of blood supply. Heart disease is the leading cause of death in the United States. Other names for heart attack include acute myocardial infarction, coronary thrombosis, and coronary occlusion.
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