New Pacemaker Device Gets FDA Approval to Treat Heart Failure
Pacemakers are widely used to get hearts that beat too slowly or irregularly into a normal rhythm. Medtronic's souped-up pacemaker works another way, boosting the beats of weak hearts. Medtronic beat two competing companies to get the device to market.
"It's a big breakthrough," said David B. DeLurgio, MD, an Emory University cardiologist who helped test the device for Medtronic. "It's not for every heart failure patient, but a proportion could definitely benefit."
In a study of 579 patients, those using the pacemaker experienced significant improvement, FDA reviewers concluded in approving the device.
One standard heart failure test measures how far patients can walk in six minutes. Those whose pacemakers were turned on could walk, on average, 58 more yards than patients in a comparison group whose pacemakers were turned off.
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.