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
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
"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.