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New Pacemaker Device Gets FDA Approval to Treat Heart Failure

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By another measure, 68% of pacemaker patients reported improved quality of life, as opposed to 38% in the comparison group.

The study lasted just six months and didn't measure whether the device had any effect on prolonging life. But doctors say that for these patients, improving quality of life in the short term is a big goal.

"It's not a new heart, but it's an improvement," said FDA medical reviewer Bram Zuckerman, MD.

InSync is only for advanced patients unaided by the best medical therapy, he said, cautioning that it's not a replacement for medications.

Because InSync is different than standard pacemakers, with an additional wire snaked into a different part of the heart, the FDA is requiring Medtronic to specially train doctors before they can begin implanting the device.

But Minneapolis-based Medtronic is prepared to begin selling the device to trained doctors immediately and says the operation should cost between $10,000 and $12,000.

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