Aug. 28, 2001 (Washington) -- The FDA approved a novel type of pacemaker Tuesday, which could offer new hope to thousands of patients who have heart failure.
With the government's approval today, Medtronic Inc.'s InSync technology will become available to appropriate patients in September, says Marshall Stanton, MD, medical director of the company's cardiac rhythm management business.
People with the disease have a weakened heart that is unable to pump enough blood for the patient to stay healthy. The weakening can happen as a result of a heart attack, high blood pressure, and infection, as well as unknown reasons. Patients gradually lose their ability to be active and can become so short of breath and fatigued that, eventually, any movement becomes difficult. Half of the patients with the disease don't live more than five years.
Doctors can use many different types of drugs to make it easier for the heart to pump blood. But while medication can be used to lighten the load on the heart, some complications of heart failure can't be treated with drug therapy.
Stanton says of the 5 million people with heart failure in the U.S., about a third develop a problem where the heart becomes even less efficient. The two pumping chambers in the heart that take turns filling up and squeezing out blood to the body no longer work in the right rhythm.
The InSync system, he says, is designed to help get the different parts of the patient's heart working together again. The InSync pacemaker delivers an electrical impulse -- from a small pulse generator implanted in the chest -- down three wires attached to the heart -- that makes the heart's pumping chambers work together.
The patient probably will still have some degree of heart failure, he says, but the device helps doctors to regain some of the heart's pumping performance. And that could mean that a person could be more active, breathe easier, and feel less fatigued.
The technique is called cardiac resynchronization and cardiologists estimate it could help some 750,000 advanced heart failure patients who can't be helped by today's best medicine.
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.