The FDA has approved a new type of replacement heart valve that can replace the pulmonary valve without open heart surgery. For patients who need a pulmonary valve replacement due to a heart defect, this is great news. While some patients may still opt to have open heart surgery, patients who cannot tolerate the rigors of surgery now have an alternative.
Clinical studies in America and Europe have shown the device, called the Melody Transcatheter Pulmonary Valve, is effective and improves heart function. The device was approved in the United States under a little used FDA program, the Humanitarian Device Exemption, which expedites the approval of devices expected to treat 4,000 or less patients per year.
Instead of opening the chest and the heart to work on the valves, this device is threaded through the large blood vessels of the groin, and threaded up and into the heart, where work is done from the inside of the heart. While the procedure is not risk-free, it is far safer than open heart surgery and recovery is much quicker.
While this valve will not be used extensively, future versions may replace other heart valves, and could be used on a far greater number of patients in need of heart valve replacement.
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