Saturday, September 29, 2012

FDA approved the first subcutaneous heart defibrillator

Yesterday, the FDA approved the S-ICD System, the first subcutaneous heart defibrillator. Unlike other heart defibrillators, the S-ICD System uses leads that are implanted just under the skin (subcutaneously) instead of connected directly into the heart. Is this going to be a game-changer, or will standard defibrillators continue as the standard of care?

From the FDA press release:

The Subcutaneous Implantable Defibrillator (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 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.”

The S-ICD System is approved to provide an electric shock to the heart (defibrillation) when the patient’s heart is beating at a dangerous level or abnormally fast (ventricular tachyarrhythmias). It is approved only for patients who do not require a pacemaker or pacing therapy.

The S-ICD System is manufactured by Cameron Health Inc. of San Clemente, Calif.

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