Subcutaneous ICD Gains FDA Approval

The FDA today approved the Subcutaneous Implantable Defibrillator (S-ICD) system from Cameron Health. The device is the first ICD that does not require a lead that connects directly to the heart and  therefore  does not need to be guided with x-ray fluoroscopy. Instead, the S-ICD lead is implanted along the bottom of the rib cage and breast bone.