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From the Food and Drug Administration
November 7, 2001

Pacemaker for Congestive Heart Failure

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Copyright 2001 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.2001American Medical Association

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JAMA. 2001;286(17):2085. doi:10.1001/jama.286.17.2085-JFD10010-3-1

The FDA has approved InSync Biventricular Cardiac Pacing System (Medtronic Inc, Minneapolis) for reduction of symptoms of moderate-to-severe heart failure in patients who remain symptomatic despite stable, optimal medical therapy and have a left ventricular ejection fraction of 35% or less and QRS duration of 130 milliseconds or more. In addition to one channel for atrial pacing and sensing, the device has two channels for simultaneous biventricular pacing and sensing from two ventricular leads. The device is noninvasively programmable and has activity-based responsive pacing capabilities.

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