FDA approves additional indication for two transcatheter heart valves
Qualifying patients must have an intermediate risk for either death or complications connected to open-heart surgery.
Until now, these two transcatheter heart valves were only approved for patients who had a high or great risk for either complications or death during their surgeries.
As people age, aortic valve stenosis can happen as the aortic valve continues to shrink. This means that the heart needs to work harder than before in order to provide the body with enough blood, pumping it through a tiny opening.
This health condition is found in approximately 3 percent of U.S. citizens who are more than 75 years old. It can cause chest pain, fainting, irregular heart rhythms, heart failure, cardiac arrest, even death.
“This is the first time in the U.S. that a transcatheter aortic valve has been approved for use in intermediate risk patients,” Dr. Bram Zuckerman, director of the division of cardiovascular devices at the FDA’s Center for Devices and Radiological Health, said. “This new approval significantly expands the number of patients indicated for this less invasive procedure for aortic valve replacement.”
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