Medtronic's Melody transcatheter pulmonary valve (stent)Without having to jump through the usual hoops required by the US
Food and Drug Administration for approval, the medical device company, Medtronic, gained approval of its Melody transcatheter pulmonary valve
through a "Humanitarian Device Exemption." This device could save
those with pulmonary valve failure many open heart surgeries... and
Medtronic has other heart valve devices lined up.
There are four heart valves: the aortic valve, the pulmonary valve, the mitral valve, and the tricuspid valve. These valves open and close to help keep blood flowing in one direction. When any valve doesn't function properly, due to a birth defect or serious impairment from disease, blood can't maintain an even flow and, in the case of the pulminary and aortic valves, may even leak back into the heart.
Those with heart valve disease may have to go through several surgeries over a long period of time before the diseased valve either functions properly or is replaced with a functional artificial valve. Medtronic's Melody pulmonary valve, which controls blood flow from the heart to the lungs, can save some of those surgeries by offering a temporary blood conduit until an open heart surgery can be performed. Ideally, the Medody System will result in improved conduit function and a lengthened life of the conduit between surgeries.
The Melody pulmonary heart valve, enveloped in a stent, is introduced through a catheter into a leg vein and guided to the heart, where the new valve is released and takes over the conduit function of the diseased valve.
The Melody transcatheter pulmonary valve has been tested on approximately 170 patients in the US and Europe and the device improved function of the heart and reduced some clinical symptoms in the majority of the cases. The FDA will require Medtronic to conduct further tests, maintain a data base of patients, and conduct physician training programs.
The Humanitarian Device Exemption, or Humanitarian Use Device (HUD), "is a device that is intended to
benefit patients by treating or diagnosing a disease or condition that
affects or is manifested in fewer than 4,000 individuals in the United
States per year. A device manufacturer`s research and development costs
could exceed its market returns for diseases or conditions affecting
small patient populations. The HUD provision of the regulation provides
an incentive for the development of devices for use in the treatment or
diagnosis of diseases affecting these populations." (FDA
Sources: Medtronic, American Heart Association, Wall Street Journal