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New Heart Defibrillator Approved

by Rathi Manohar on March 30, 2011 at 12:03 AM
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 New Heart Defibrillator Approved

A new heart defibrillator that avoids unnecessary shocks, designed by the well-known medical device manufacturer, Medtronic has been approved by the FDA.

The device, Protecta, has been designed to administer shocks only when it identifies any life-threatening change in the heart's rhythm. While the majority of shocks delivered are necessary to treat potentially fatal arrhythmias, 20% of patients may experience inappropriate shocks. 61% of patients who received an inappropriate shock have to visit the hospital, clinic or emergency room at least once within three days of receiving therapy.

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This implantable heart device that uses updated programming to monitor the heart's rhythm limits the shocks to life-threatening situations. The company states that this new device will keep patients free from unnecessary shocks five years after implantation.

Although the FDA had issued a warning letter against Protecta because of quality control issues, the warning has now been lifted. Medtronic has faced other problems too, involving sales and marketing and retrenchment.
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The FDA approval has been much-sought and Pat Mackin, president of Medtronic's heart rhythm unit says, "The Protecta family of devices addresses one of physicians' top needs -- allowing them to better serve patients by providing devices that are designed to deliver a shock only when needed to save a life."  



Source: Medindia
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