FDA approves first subcutaneous heart defibrillator

Monday, October 1, 2012 11:51 AM

The FDA has approved Cameron Health’s subcutaneous implantable defibrillator (S-ICD) system, a heart defibrillator that helps to restore regular heart rhythms with leads that can be implanted subcutaneously instead of connected directly into the heart.

The 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 system is approved only for patients who do not require a pacemaker or pacing therapy.

"The S-ICD System provides an alternative for treating patients with life-threatening heart arrhythmias for whom the routine ICD placement procedure is not ideal," said Christy Foreman, director of the office of device evaluation at FDA's Center for Devices and Radiological Health. "Some patients with anatomy that makes it challenging to place one of the implantable defibrillators currently on the market may especially benefit from this device."

FDA has reviewed data from a 321-patient study in which 304 patients were successfully implanted with the S-ICD system. At the time of implantation, the investigator 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. Investigators followed these patients for six months following implantation, during which time the device detected and recorded 78 spontaneous arrhythmias in 21 patients; all arrhythmias were either successfully converted back to normal by the defibrillator or resolved on their own. Because the S-ICD system memory stores data from only the 22 most recent arrhythmia episodes, there may have been other detected episodes that could not be analyzed by investigators.

As part of the approval, FDA is requiring the manufacturing company to conduct a post-market study to assess the long-term safety and performance of the device and to assess differences in effectiveness across genders. The study will follow 1,616 patients for five years.

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