Sudden cardiac death remains a major threat despite advances in medication and
other treatments for preventing recurrent heart attacks and heart failure. Each
year, it claims the lives of more than 400,000 Americans alone, and the
overwhelming majority of those deaths are caused by ventricular fibrillation,
or rapid, uncoordinated contractions.
Randomized trials have shown that implantable defibrillators dramatically
reduce mortality in patients with a history of arrhythmias, or abnormal heart
rhythms caused by ventricular fibrillation, or in patients at risk for sudden
cardiac death. Today, the patient population of defibrillator candidates is
significantly underserved. Without a defibrillator, a victim of sudden cardiac
arrest has only a five-percent chance of survival. Implantable defibrillators
currently on the market, however, are similar in form and function: titanium
boxes implanted in the pectoral region. In most patients, this device creates a
"cardiac bump" that is visible when not covered by loose-fitting clothes. The
implant procedure typically requires hospitalization, followed by frequent
device adjustments of complex features that few have the time or requisite
skills to fully interpret or optimize.








