FDA APPROVES BROADER USE OF ELECTRICAL HEART DEVICE.Byline: The New York New York, state, United States
New York, Middle Atlantic state of the United States. It is bordered by Vermont, Massachusetts, Connecticut, and the Atlantic Ocean (E), New Jersey and Pennsylvania (S), Lakes Erie and Ontario and the Canadian province of Times
The Food and Drug Administration on Thursday approved expanded uses of an electrical device that regulates ailing hearts, because studies showed that the change could save thousands of lives a year.
The agency said it had approved the broader use of the device, called an implantable defibrillator defibrillator, device that delivers an electrical shock to the heart in order to stop certain forms of rapid heart rhythm disturbances (arrhythmias). The shock changes a fibrillation to an organized rhythm or changes a very rapid and ineffective cardiac rhythm to a , just six days after receiving an application for the change from the manufacturer, CPI Guidant, of St. Paul, Minn., a subsidiary of Guidant Corp. of Indianapolis, as well as study data from researchers.
An FDA FDA
Food and Drug Administration
n.pr See Food and Drug Administration.
n.pr the abbreviation for the Food and Drug Administration. spokeswoman, Sharon Snider, said that some doctors were already implanting the devices for the new uses, but that Thursday's action would make this accepted practice.
``We moved very rapidly on this approval,'' Snider said, ``because of its significance to public health and the quality of the data submitted from the study. This is the first approval for this use anywhere in the world.''
Defibrillators, either the implanted type or the electrical paddles used by emergency medical workers, send strong jolts to the heart to restart it after a heart attack or cardiac arrest cardiac arrest
Abbr. CA A sudden cessation of cardiac function, resulting in loss of effective circulation.
A condition in which the heart stops functioning. . The implanted type sends a jolt when the heart begins beating rapidly and erratically, which could lead to a heart attack or sudden arrest.
Dr. Arthur Moss, a professor of medicine at the University of Rochester Medical Center The University of Rochester Medical Center (URMC), located in Rochester, New York, is one of the main campuses of the University of Rochester and comprises the university's primary medical education, research and patient care facilities. who led a test that proved the value of the new use, said the surgically implanted defibrillators send strong pulses of electrical energy to selected parts of the heart to force it into the proper rhythm.
Tests conducted at 32 hospitals in the United States Lists of hospitals for each U.S. state: