On September 28, 2012, the US Food and Drug Administration announced the approval of a of a heart defibrillator that is not directly connected into the heart.  The defibrillator, called a Subcutaneous Implantable Defibrillator System, sits just under the skin at the bottom of the breast bone and rib cage.

For the first time ever, the defibrillator does not require a doctor to use X-ray fluoroscopy during the implanting of the device.  Other defibrillators on the market require the physician to place one or more wires or “leads” into a vein that travel to the heart.  In order to perform such a procedure, the physician needs to use the real-time imaging in order to see the heart and blood vessels and guide the wire.  

The new device is just as effective as standard heart defibrillators.  The device will only send a shock when a person’s heart is beating irregularly or too fast in order to prevent cardiac arrest.  

In order to approve the device, the FDA conducted a study of 321 patients who needed a heart defibrillator.  Out of all the patients, 304 successfully received the new defibrillator, called S-ICD for short.  The FDA then tested the patients over a six month period of time.  A total of 78 arrhythmias were reported in 21 different patients, and all of the arrhythmias were corrected by the device or on their own.  

The FDA reports that some common complications occurred during the study.  About 10 percent of patients noticed unneeded shocks, discomfort, infection, or movement of the electrodes.  8 patients died during the study, but the FDA does not state the defibrillator was the direct cause of death.  

Christy Foreman, the director at the Office of Device Evaluation, states: “The S-ICD System provides an alternative for treating patients with life-threatening heart arrhythmias for whom the routine ICD placement procedure is not ideal.  Some patients with anatomy that makes it challenging to place one of the implantable defibrillators currently on the market may especially benefit from this device.”  

Source: Food and Drug Administration