Medtronic Inc.'s InSync system works by boosting the heart's pumping power. The technique is called cardiac resynchronization, and cardiologists estimate it could help some 650,000 advanced heart failure patients who can't be helped by today's best medicine.
"It's a big breakthrough," said Dr. David B. DeLurgio, 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."
Almost 5 million Americans have congestive heart failure. It's not a heart attack or sudden heart stoppage. Instead, a heart weakened by age, damage from a survived heart attack or some other disease gets flabbier as it struggles to push blood out to the rest of the body.
Eventually, patients are pressed even to walk across a room. Fluid seeps into their lungs, blocking breathing. Just half survive five years or more. When medications fail, a heart transplant is the only option, but many patients are too old to qualify.
Enter the new therapy.
Pacemakers are widely used to zap 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.
Up to half of heart failure patients have hearts whose main pumping chambers, the left and right ventricles, don't beat simultaneously, sapping the heart's power. The InSync pacemaker delivers an electrical impulse from a small pulse generator in the chest down three wires implanted in the heart that makes the ventricles pump together.
In a study of 579 patients, those using the pacemaker experienced significant improvement, Food and Drug Administration 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 percent of pacemaker patients reported improved quality of life, as opposed to 38 percent 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 Dr. Bram Zuckerman.
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 o specially train cardiologists before doctors can begin implanting the device.
But Minneapolis-based Medtronic is prepared to begin selling the device to trained physicians immediately, and says the operation should cost between $10,000 and $12,000.
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