Implantable Defibrillator Cleared by FDA

Food and Drug Administration (FDA) for treating potentially lethal heart rhythms such as ventricular fibrillation, which can lead to sudden cardiac arrest.

The ICD, called Gem III VR, is the product of Medtronic, Inc. (Minneapolis, MN, USA) and is a companion to the company's dual-chamber version (Gem III DR). The FDA has also announced the clearance of Medtronic's new quadripolar, right ventricular electrical conduction lead, Sprint Quattro. This steroid-eluting lead offers bipolar sensing with dual defibrillation coils in the smallest quadripolar lead body now available.

The company notes that ICDs have been clinically proven to be 99% effective in saving victims of lethally rapid heart rhythms in the lower chambers of the heart. Once implanted, an ICD constantly monitors the heart's rhythm and automatically delivers electrical therapy when needed to interrupt a life-threatening arrhythmia and restore the heart to a normal rhythm.



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