WEDNESDAY, Aug. 29, 2001 (HealthDayNews) -- It's not to be confused with the popular singing group that electrifies young people, but a new kind of heart pacemaker called InSync might have the same effect on those who suffer from congestive heart failure.
The FDA has approved InSync, made by Medtronic, Inc. of Minneapolis, for the symptoms of congestive heart failure, a condition that occurs often in the elderly. The heart can't pump enough blood through the body, causing fatigue, shortness of breath and performance problems with simple tasks. In the most dramatic cases, fluid accumulates in the lungs and around the heart, and this can be fatal.
Standard pacemakers treat heart rhythm disturbances, a separate problem. Patients who have benefited from InSync in clinical trials are those who have non-synchronized heart ventricles. This Talk Paper from the FDA explains the unique properties of InSync.
The device is placed surgically in the chest and connected to the heart by three wires, sending electrical impulses as needed to the upper
right heart chamber and each of the two lower chambers. This brings the heart beat into the proper rhythm.
Medtronic researchers studied the device in 579 U.S. and Canadian patients with moderate to severe congestive heart failure. Improvement in quality of life in many of the patients prompted the FDA approval. And while the quality of life improved, mortality rates remained the same. As part of the approval, the FDA stipulated that Medtronic perform a follow-up three-year study with 1,500 patients.
Nearly five million Americans suffer from congestive heart failure, with about 550,000 new cases diagnosed each year.
For more information about congestive heart failure, go to the American Heart Association's special site on this subject.
