New FDA Approved Medtronic ICD Only Shocks Heart When Necessary

A new implantable defibrillator (ICD) has been approved by the U.S. Food and Drug Administration this week that is “smart” and will only administer a shock when it detects life-threatening arrhythmia, or a disorder of the heart rate (pulse) or heart rhythm, such as beating too fast (tachycardia), too slow (bradycardia), or irregularly.

The new family of implantable defibrillators features SmartShock Technology, which includes six new Medtronic-exclusive algorithms that recognize life-threatening arrhythmias and deliver therapeutic shocks only when appropriate therefore enhancing patient quality of life.

Based on studies, 98% of patients with SmartShock Technology will be free of inappropriate shocks one year after implant and 92% will be free of inappropriate shocks five years after implant.

Pacemakers and ICDs are different in some respects. A pacemaker monitors the electrical impulses in the heart. When needed, it delivers electrical pulses to make the heart beat in a more normal rhythm. A pacemaker may be helpful when the heart beats too slowly or has other abnormal rhythms. An ICD is a device that monitors heart rhythms. If it senses dangerous rhythms, it delivers shocks. Many ICDs record the heart’s electrical patterns when there is an abnormal heartbeat. This can help a doctor plan future treatment.

Pacemakers can only give off low-energy electrical pulses. They’re often used to treat less dangerous heart rhythms, such as those that occur in the upper chambers of your heart. Most new ICDs can act as both pacemakers and defibrillators.

Kent Volosin, M.D., cardiologist at the University of Pennsylvania in Philadelphia states in a press release:


“With recent studies showing that up to one in five patients may experience inappropriate shocks, this new technology can significantly mitigate that concern and will have a real-world impact on my patients’ lives by improving quality of life.”

The manufacturer, Medtronic, estimates more than 70,000 lives have been saved worldwide by implantable defibrillators over the past five years. Implantable defibrillators are designed to provide lifesaving shocks or painless pacing to stop life-threatening fast or irregular heartbeats, also known as ventricular arrhythmias, which can lead to sudden cardiac death.

While the majority of shocks delivered are necessary to treat potentially fatal arrhythmias, studies estimate that up to 20% of patients with implantable defibrillators may experience inappropriate shocks in response to a benign arrhythmia or electrical noise sensed by the device. Additionally, data show that 61% of patients who received an inappropriate shock visited the hospital, clinic or emergency room at least once within three days of receiving therapy.

An ICD has wires with electrodes on the ends that connect to your heart chambers. The ICD will continually monitor your heart rhythm. If the device detects an irregular rhythm in your ventricles, it will use low-energy electrical pulses to restore a normal rhythm.

If the low-energy pulses don’t restore your normal heart rhythm, or if your ventricles start to quiver rather than contract strongly, the ICD will switch to high-energy electrical pulses for defibrillation. These pulses last only a fraction of a second, but they can be painful.

Pat Mackin, president of the Cardiac Rhythm Disease Management business and senior vice president at Medtronic adds:


“The Protecta family of devices addresses one of physicians’ top needs, allowing them to better serve patients by providing devices that are designed to deliver a shock only when needed to save a life. This new innovation is the latest example of Medtronic’s 20 year leadership in shock reduction technology through product innovation backed by industry-leading clinical research.”

Source: Medtronic News Room

Written by Sy Kraft, B.A.

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