fda.gov (September 28, 2012) — The U.S. Food and Drug Administration today approved a heart defibrillator that helps to restore regular heart rhythms with leads that can be implanted just under the skin (subcutaneously) instead of connected directly into the heart.
An implantable defibrillator is a small battery-powered device that constantly monitors a person’s heart rhythm and can deliver a therapeutic dose of electricity to restore the rhythm when it senses the heart is beating dangerously fast (tachycardia) or chaotically (sudden cardiac arrest).
Other implantable defibrillators on the market require a physician to insert one or more electrical conductor wires, called “leads,” into a vein in the upper chest and guide them into the patient’s heart. X-ray fluoroscopy, a real-time imaging method, helps the physician to visualize the heart and blood vessels to guide the leads to the correct position.
The Subcutaneous Implantable Defibrillator (S-ICD) System uses a lead that is implanted just under the skin along the bottom of the rib cage and breast bone. Because the lead is placed under the skin rather than through a vein into the heart, a physician can implant the device without accessing a patient’s blood vessels or heart and without the need for fluoroscopy.
“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,” said Christy Foreman, director of the Office of Device Evaluation at FDA’s Center for Devices and Radiological Health. “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.”
The S-ICD System is approved to provide an electric shock to the heart (defibrillation) when the patient’s heart is beating at a dangerous level or abnormally fast (ventricular tachyarrhythmias). It is approved only for patients who do not require a pacemaker or pacing therapy.