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FDA Approves Unique Heart Device

Leads implanted under the skin instead of into the heart (Sept. 28)

On September 28, the FDA 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. The device 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 (leads) into a vein in the upper chest and to 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 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.

The FDA has reviewed data from a study in which 304 patients were successfully implanted with the S-ICD system. At the time of implantation, the investigators tested the effectiveness of the device by inducing heart arrhythmias. The S-ICD system was successful at converting all abnormal heart rhythms that it detected back to normal rhythms. The investigators followed the patients for 6 months after implantation, during which time the device detected and recorded 78 spontaneous arrhythmias in 21 patients; all of the arrhythmias were either successfully converted back to normal by the defibrillator or resolved on their own.

As part of the approval, the FDA is requiring the manufacturer — Cameron Health Inc. of San Clemente, Calif. — to conduct a postmarket study to assess the long-term safety and performance of the device and to identify differences in effectiveness across genders.

For more information, visit the FDA Web site.

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