Register for FDA approves new indication for implantable cardioverter defibrillators
Cardiac ArrestAugust 12, 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 undergo this electrical testing prior to the implantation of the ICD.
ICDs are devices that detect fatal heart rhythms and treat them by shocking the heart back into a normal rhythm. They are implanted under the collarbone and one or more leads (insulated wires) are placed directly into the chambers of the heart.
The FDA based its approval on the results of a large multicenter, randomized, controlled clinical trial sponsored by the Guidant of Indianapolis, Indiana. More than 1200 patients were enrolled in the study: 742 received an ICD and the remaining 490 patients were treated with medical therapy alone.
The study demonstrated a 31% reduction in the risk of death in patients who had an ICD compared with those in the medical therapy group.
A small percentage of patients (3%) had complications from the device, but there were no deaths associated with it. Although ICD patients had a better survival rate than those on medical therapy, the ICD patients were more likely to be hospitalized during the study for congestive heart failure.
The expanded approval means that currently approximately 3-4 million people in the United States might be candidates for an ICD. This article was prepared by Medical Devices & Surgical Technology Week editors from staff and other reports.
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