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Doctor Says New Medical Device May Not Be Safe

Posted on in Defective Medical Devices

The new lead free implantable heart defibrillator, invented by Boston Scientific Corp, should not be used on a regular basis until more data is available, according to a story in the Chicago Tribune. Defibrillator leads have often caused problems for device makers. Boston Scientific bought the new technology, known as a subcutaneous implantable cardioverter-defibrillator, or S-ICD, last year. “The S-ICD has not yet been shown to be safe and effective in a diverse patient population,” said Robert Hauser of the Minneapolis Heart Institute. He also pointed out that the lead free defibrillator is not even as good as the traditional ICDs that have leads.

According to Hauser, the new technology shows a lot of promise and could fill important gaps, especially in countries where facilities to implant traditional devices do not exist. However, it is necessary to obtain more data first in order to ensure the safety of the device. “Unless critical questions with regard to safety and efficacy in primary and secondary prevention are addressed, the S-ICD should be confined to certain subgroups,” Hauser said.

Boston Scientific's Chief Medical Officer said in an interview that the device has been approved by the FDA “as being safe and effective.” However, patients who have a slow heartbeat or uncoordinated pumping function should definitely not get the S-ICD because it is not capable of pacing a slow heartbeat or resynchronizing heart ventricle contractions. In some cases, the device may be a better option for patients who are at risk for a severe blood infection.

New medical devices may have unexpected side effects. If you or a loved one has had problems with a faulty medical device, you may be entitled to compensation. Don't go through it alone. Contact an experienced defective medical device attorney in Illinois as soon as possible.

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