The implantable cardioverter defibrillator is a small battery-powered device that continuously monitors the patient's heart rhythm. When a tachycardia or cardiac arrest is detected, a therapeutic dose of electricity can be provided to restore the rhythm of the heartbeat.
Other implantable defibrillators on the market require a doctor to insert one or more lead wires (electrodes) into the upper thoracic vein and guide it to the patient's heart, using X-ray fluoroscopy (a real-time imaging technique) to help The doctor visualizes the heart and blood vessels and directs the electrodes to the correct position.
The subcutaneous implantable defibrillator system utilizes an electrode implanted along the skin of the ribs and sternum. Since the electrode is implanted subcutaneously rather than through the vein into the heart, the physician does not need to know the patient's blood vessel and heart position information, and without the need for see-through, the device can be implanted.
The S-ICD system provides an electric shock to the heart when the patient's heartbeat is at a dangerous level or abnormally fast (ventricular tachycardia). This device is only approved for patients who no longer need cardiac pacemaker or pacing therapy. As part of the approval, the FDA asked Cameron Health to conduct a post-marketing study to assess the long-term safety and efficacy of the device and to assess the transgender differences in effectiveness. The study will follow up to 1616 patients for 5 years.
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