In March this year the FDA panel recommended against the device stating there was not enough evidence to show safety. The device works to fix leaky heart valves in patients who are not candidates for surgery to replace a heart valve. 30 other countries outside the US have been using the device to treat mitral regurgitation when the left chambers don’t close all the way. When this occurs the heart has to work harder.
The FDA does not always follow the panel advice and this is one example, took a while but the device was approved. This is an interventional heart procedure where a catheter is used to guide the placement in heart.
The clip moves with the heart valve and it made of metal with a coating. Ultra sound imaging is also used to help with placement. BD
(Reuters) - The U.S. Food and Drug Administration has approved Abbott Laboratories' MitraClip medical device, used to stop heart valve leakage in patients deemed unable to endure valve repair through open heart surgery, the company said on Friday.
The MitraClip treats mitral regurgitation, a condition in which the mitral valve of the heart does not close properly, causing blood leakage that can lead to stroke, heart attack or even death.
It has estimated the disorder affects about one in 10 people aged 75 and older.
Those with the condition who are too frail for open heart surgery are typically treated with medicines and have high rates of heart failure and rehospitalizations.
The MitraClip was approved in Europe in 2008 under a system in which medical devices often reach the market several years ahead of the United States. There are 20,000 to 30,000 patients in the United States who would likely qualify for MitraClip implantation, Capek said.