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Health Highlights: Dec. 11, 2008
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Doctors Call for Human Studies of New Defibrillators
Human studies must be conducted before important new technology is used in heart defibrillators, say two prominent heart doctors who helped shed light on previous medical device defects.
The new "four-pole connector" technology is a more compact way of connecting heart defibrillators to wires -- called leads -- that conduct electricity to the heart. It would allow defibrillators to be smaller and leads thinner, which would make the implant procedure easier, the Wall Street Journal reported.
The U.S. Food and Drug Administration plans to allow defibrillator makers to sell the new implantable cardioverter defibrillators (ICDs) without conducting human studies, something that "is not in the best interest of patients," cardiologists Dr. Robert G. Hauser and Dr. Adrian K. Almquist wrote in this week's New England Journal of Medicine.
The Minneapolis Heart Institute doctors said they're concerned the new technology could be prone to potentially deadly short-circuiting, the Wall Street Journal reported.
The FDA disputed the cardiologists' claim that the agency has decided to allow the new devices to be sold without human testing, the newspaper said.
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