New Pacemaker Device Gets FDA Approval to Treat Heart Failure
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.