In a recent trial, researchers compared conventional open-heart surgery to MitraClip- delivered to the heart via a catheter through a blood vessel in the leg- for their efficacies in treating mitral regurgitation, or MR. Among patients who received the MitraClip, only 9.6 percent suffered major adverse events compared with 57 percent in the surgery group, a difference considered to be highly statistically significant. In the surgery group, 42 of the 55 adverse events were major bleeding, researchers said. There were no deaths, heart attacks or major strokes among the clip patients in the study. After a year, the device was effective in 72% of patients, enabling them undertake normal physical activity.
The researchers are of the view that it would be of immense help to the elderly who are reluctant or unable to undergo open-heart surgery. “This is a stunning difference in safety for an acceptable trade-off in efficacy for many patients,” said Dr.Ted Feldman, director of the cardiac catheterization laboratory at NorthShore University HealthSystem in suburban Chicago.
Mitral regurgitation (MR) is a condition wherein a fault in the valves causes blood to flow backward in the heart. This condition affects nearly 250000 people in the nation every year. MitraClip functions by clipping the leaflets of the mitral valve, preventing the backward flow of blood.
According to John Capek, executive vice president of medical devices for Abbott, if MitraClip is approved in the United States, Abbott would have exclusivity in the market for a couple of years at least.
Written by Snigdha