1. How does the Cameron Health S-ICD System work? Just as your physician places wires on your chest to monitor your heart during an electrocardiogram or ECG, the S-ICD System similarly monitors your heart with a wire just under the skin. The S-ICD System is the only implantable defibrillator that uses an ECG-like signal to monitor your heart for abnormal rhythms that indicate sudden cardiac arrest. The S-ICD system is designed to accurately treat sudden cardiac arrest when you need it, and it may also reduce the likelihood of receiving unnecessary shocks.
2. What is the difference between the S-ICD System and a traditional ICD? The S-ICD System is the only implantable defibrillator that does not require electrical wires in your heart. The S-ICD System is implanted using a completely subcutaneous procedure that leaves the heart and blood vessels untouched and intact. By placing the electrode just under the skin, the S-ICD System eliminates potentially serious short- and long-term risks associated with placing electrical wires inside your heart or blood vessels.
3. How does a shock restore my heart rhythm? When the S-ICD System senses a dangerous heart rhythm, it will send an electrical pulse to your heart to reset your heart’s normal rhythm and allow your heart to resume pumping blood through your body.
4. What does a shock feel like? People have reported a wide range of experiences as a result of receiving a shock, from a mild thump to a kick in the chest. While the shock may be painful, this means your S-ICD System is monitoring and responding to dangerous heart rhythm irregularities.
5. Is defibrillation dangerous? ICDs are a safe treatment option that have been used for decades and have prolonged hundreds of thousands of lives. Without defibrillation, if your heart beats too quickly, you may experience sudden cardiac death. There are risks associated with implantation. Talk to your physician about those risks.
6. Are there risks associated with traditional ICDs? Like any other medical device implanted in the body, there are some risks, such as infection and bleeding. These include leads that are implanted directly in the heart, complications with lead wires, lead failure, vein complications, and removal of leads. Other risks associated with implantable defibrillators include delivery of inappropriate therapy. Your physician is the best source of information about the risks of traditional ICDs. Be sure to talk with your physician about all of your questions and concerns.
7. What are the risks associated with the S-ICD System? The S-ICD System has been designed to reduce complications associated with traditional ICD electrical wires. However, the S-ICD System implantation, like every surgical procedure, does carry risks, including infection and bleeding. As with any ICD, there is a risk of delivery of inappropriate therapy. Your physician is the best source of information about the risks of having the S-ICD System. Be sure to talk with your physician about all your questions and concerns. The S-ICD System is investigational in the United States. In the United States, the S-ICD System is only available at hospitals participating in an FDA-approved clinical study.
8. How is the S-ICD System implanted? During the procedure, your surgeon will make three incisions. First, a small incision is made on the left side next to the rib cage where the pulse generator will be placed. Then, two small incisions will be made slightly to the left of the breastbone for the electrode. Once the S-ICD System is programmed, your physician will close the incisions to complete the procedure.
9. Are S-ICD Systems available worldwide? Yes, currently they are available in Europe and as an investigational device in the United States. The S-ICD System is only available at hospitals participating in an FDA-approved clinical study in the United States.
10. Can I enroll in the clinical trial? The clinical trial is only open to qualified candidates in the United States. Call 1-877-SICD-411 to talk to one of our Cameron Health US Customer Service Representatives for enrollment and eligibility information.
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