The approval of the new indication is based on a study of 614 patients with heart failure who had moderate-to-severe or severe secondary mitral regurgitation and were randomly assigned to get either continuation of their optimized medication treatment plus the MitraClip (MitraClip group) or continuation of their optimized medication treatment only (control group). The risk of being re-hospitalized for heart failure symptoms was reduced by approximately 47 percent in the MitraClip group compared to the control group. In addition, the risk of death within two years was decreased by approximately 37 percent in the MitraClip group compared to the control group.
Potential adverse events from the device and implant procedure include death, stroke, major bleeding, and erratic heart beat (atrial fibrillation).
The MitraClip is contraindicated in patients who cannot tolerate blood thinners during or after the procedure, who have active inflammation (endocarditis) of the mitral valve, rheumatic mitral valve disease or evidence of blood clots in the heart or veins leading to the heart.
The MitraClip Clip Delivery System is manufactured by Abbott Vascular Inc.
FDA: Medical Devices
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
SOURCE U.S. Food and Drug Administration
Back to HCB News
