Biventricular Pacing System Treats Congestive Heart

The device has been cleared by the U.S. Food and Drug Administration (FDA) and has also received the CE Mark from the European Union.

InSync is designed to treat heart failure caused or exacerbated by left ventricular sysnchrony, which occurs when there is a time delay between the beating of the heart's two lower chambers. The device comprises a small pulse generator that is implanted beneath the skin in the shoulder and delivers the shocks.

Until now, only prescription drugs have been approved by the FDA for the treatment of heart failure. InSync is the product of Medtronic Inc. (Minneapolis, MN, USA; www.medtronic.com), which says it now has an advantage over rival Guidant, Inc. (Indianapolis, IN, USA), which failed to receive FDA clearance in July for a similar device. "Approval of this first-generation InSync system opens the door for additional device-based options that will continue to advance the treatment of heart failure and the quality of life for thousands of these patients,” noted Steve Mahle, president, Medtronic Cardiac Rhythm Management.




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