MADIT II
Recently, Guidant's implantable defibrillators were approved for expanded indication by the FDA. This ruling was based on results from the landmark Multicenter Automatic Defibrillator Implantation Trial (MADIT) II. The trial indicated that use of Guidant's implantable defibrillators (ICDs) could potentially reduce mortality for heart attack survivors with impaired heart function -- namely, those whose ejection fractions are at or below 30 percent. In the ruling, the FDA stated that the defibrillators could protect the lives of at least 3 million heart attack survivors. Guidant is currently the only manufacturer of implantable defibrillators to have this approved labeling.

Implications of the Study
An important result of the MADIT II trial is the shift in philosophy for post-heart attack care. We now know that a heart attack can significantly lower one's ejection fraction, which, in turn, raises the risk of sudden cardiac death (SCD). According to the North American Society of Pacing and Electrophysiology (NASPE), sudden cardiac death (SCD) causes the death of more than 300,000 Americans each year. As a heart attack survivor, it is important that you and your doctor are aware of three numbers: your cholesterol, your blood pressure, and your ejection fraction. By educating yourself on these three aspects of your cardiac health, you will take one step closer toward preventing SCD.

"People now should know this like what their blood pressure is, what their cholesterol level is and what their ejection fraction is. Low ejection fraction identifies a high risk for Sudden Cardiac Death, and at the present time the only treatment, the only preventive treatment for Sudden Cardiac Death is in fact the implantable defibrillator. There are no effective drugs to prevent Sudden Cardiac Death, which makes up about half of the death in individuals who have low ejection fractions."
- Dr. Arthur Moss, principal investigator of the MADIT II trial

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