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  (Source: soraccophoto.com)
Device was commercially approved in Europe in 2006, and now, the FDA has approved its use in the United States

An Oregon Health & Science University (OHSU) Doernbecher Children's Hospital pediatric cardiac team has made a successful breakthrough in the treatment of heart disease/defects. 

Dr. Grant Burch, M.D., associate professor of pediatric cardiology at OHSU Doernbecher Children's Hospital and director of the OHSU Pediatric and Adult Congenital Cardiac Catheterization Lab, and Laurie Armsby, M.D., Burch's partner in the OHSU Pediatric and Adult Congenital Cardiac Catheterization Lab and associate professor of pediatric cardiology at OHSU Doernbecher Children's Hospital, have used a device to implant a pulmonary heart valve without the use of open-heart surgery.  

The device is called the Medtronic Melody Transcatheter Pulmonary Valve, and it is used to replace a leaky or narrow pulmonary valve conduit in adults and children that have already had surgery to fix a congenital heart defect. This tool was recently approved by the Food and Drug Administration (FDA), and does not require open-heart surgery. It was first approved for commercial use in Europe in 2006, and since then, over 1,700 patients have been implanted with the pulmonary valve. Now, according to the FDA, 1,000 U.S. citizens with congenital heart disease will qualify for the Melody valve each year.

"Children born with blocked or leaky heart valves can undergo as many as four open-heart surgeries before reaching adulthood to replace conduits that have worn out or that they've outgrown, and each time the risk of surgery goes up," said Burch. "The Melody extends the useful life of an implanted valve conduit and is very likely to reduce the number of open-heart operations a patient might require over a lifetime."

The Melody is placed into a small opening in a patient's leg and is led by a catheter through blood vessels into the heart. A balloon on the end of the catheter is inflated once the valve is positioned in place, which delivers the valve and corrects blood flow

"The remarkable thing about this procedure is that the valve is placed into the beating heart through a vein in the patient's leg," said Armsby. "After the procedure, patients spend a night on the hospital ward and are discharged home the following morning. This device brings us closer to the goal of providing children less invasive alternatives to surgery for the treatment of congenital heart disease." 

Burch noted that the Melody valve cannot eliminate the need for open-heart surgery entirely, but it can be used as a safe alternative for those with congenital heart disease. 



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By MozeeToby on 2/4/2011 1:40:11 PM , Rating: 4
The short answer: https://secure.wikimedia.org/wikipedia/en/wiki/Tha... A drug that was fully approved in Europe and Canada that was used, among other things, to treat morning sickness in pregnant women who simply could not keep food down. Fast forward four years later and you have 20,000 babies in Europe born with massive deformities... and about 17 in the US because the FDA said that 'more studies were needed'. The FDA does not accept the approval by other countries as sufficient evidence to allow a treatment to be sold in the US.

In this case, there is a tried and true treatment available. Certainly there are risks associated with that treatment but they are known risks which is preferred over the unknowns of a new, untested treatment. What if it doesn't install the valve correctly? What if the valve damages the veins on the way to the heart leading to blood clots and stokes later in life? Controlled studies are needed to determine risk factors in any new treatment and in the meantime the accepted treatment is used.

Obviously, if this were a life threatening problem with no reliable treatment the studies would be larger and approval faster in coming, but that isn't the case here.


By quiksilvr on 2/4/2011 3:40:12 PM , Rating: 2
So I guess the only way we know it would actually work is trial and error in different areas (in this case, Europe), analyze the success and failure rates, and then approve it if it is satisfactory in the states.


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