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Petitioning Center for Devices and Radiological Health U.S. Food & Drug Administration

FDA: Approve humanitarian use of the Melody® valve, and save children who need it right now

Our children are alive and thriving because of the innovative use of the Melody® valve. Unfortunately, many other children who need this valve right now to survive are not getting it. They won’t get it unless the FDA and Medtronic (the device maker) work together to make it happen.

Until now, many infants and toddlers who have severe mitral valve (heart) disease have had little chance of survival. Doctors led by a team at Boston Children’s Hospital have been using the Melody® valve – a valve intended for another use altogether – to save these children’s lives.

It’s been working. Now dozens of children (our children!) have a chance to live and thrive.

But because the valve was built for another use, some changes need to be made to it to make it best for the mitral position. Right now, doctors have to make the modifications during surgery. It would be better and safer for children if Medtronic made the modifications beforehand. Because changes need to be made, under the typical FDA testing process, these children would need to wait for years before they could get it. That is not going to work here. However, the FDA can make humanitarian use exceptions.

Some of us were lucky that our children were under the care of Boston physicians when they needed their valves. But until the Melody® gets humanitarian approval, many children who need one won’t get one. Consider Milana’s and Gideon’s stories.

Milana is the daughter of Janelle and Nick Foligno. Milana was born with severe mitral valve disease. At only days old, Janelle and Nick were told that she needed to grow before she could get a replacement valve, but doctors didn’t know how long she would survive given her severely dysfunctional mitral valve. Not content with simply watching as their daughter’s health deteriorated, through their own searching, the Folignos found their way to Boston. Milana got a Melody® valve at three weeks old, was discharged 10 days later, and has been thriving ever since.

Amanda and Shane Drause, parents of 11 week old Gideon, were in crisis. They reached out to Melody® valve parents they found online for help. The medical team at Vanderbilt Children’s Hospital wanted to place a Melody® valve in the mitral position as Gideon had dire need of it. The process was held up unduly as the health insurance company denied coverage twice. It took a major effort to get this life-saving surgery approved on appeal. Gideon now has his Melody® and is recovering.

The Folignos and Drauses had to fight to find out about the Melody®, and then get them for their children.

While our children (read more of their stories here) are thriving right now due to receiving a Melody® valve, many more are dying. Children will continue to die every year because this option is not yet widely available.

Please sign the petition to urge the FDA and Medtronic to work together to get the device to kids who need it now, and ultimately obtain humanitarian use approval of the valve. Share right now on Facebook, LinkedIn, Twitter, and any other places you can. If you have any media contacts who could help us get this petition in front of more people, please put us in touch. You can contact us here. Follow us on Facebook and Twitter and our website, melodyvalve.org.

We and our children thank you for your help and support.

Sincerely,

Mike & Erica Schultz on behalf of the parents of children with Melody® valves in their mitral positions at melodyvalve.org/our-children. 

This petition was delivered to:
  • Center for Devices and Radiological Health
    U.S. Food & Drug Administration


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