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Cardiac Arrest

FDA approves new indication for implantable cardioverter defibrillators

Published in Medical Letter on the CDC and FDA, August 18th, 2002

The U.S. Food and Drug Administration (FDA) has approved a new indication for Guidant Corp.'s implantable cardioverter defibrillators (ICDs) that expands the target population to include patients with a history of a heart attack and depressed heart function. The device is intended to prevent these patients from dying from a cardiac arrest.

The ICDs were previously approved for patients who had survived cardiac arrests and for patients who had undergone invasive electrical testing (done through a catheter from the groin to the heart) to determine if they were suitable candidates for an ICD. With the approval of this new indication, some patients may not be required to...

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