Infants and toddlers with severe mitral valve disease have, until now, had little chance at survival. Doctors 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. Dozens of children now have a chance to live and thrive.

While dozens of children are thriving today due to receiving a Melody® valve, many more will likely die this year and every year because this option is not yet FDA approved. Without FDA approval of the Melody® as a humanitarian device, children who need it won’t be able to get it. Doctors won’t know about it. Even those who do may dismiss it as experimental and not FDA approved. And as has happened to parents involved with this effort, insurance may deny coverage.

The typical FDA process to approve a medical device takes years. However, the FDA can make exceptions in certain situations—like ours—for humanitarian devices.

As parents of children with Melody® valves in the mitral positions, we feel compelled to support the effort to approve the Melody® for use in the mitral position energetically, proactively, and with a true sense of urgency.

We’re doing two things we believe can make a difference:

  1. Raise awareness of this issue. Sign the petition. Make noise on social media. Get news stories. In any way we can, we intend to influence the approval of the Melody® valve.
  2. Raise money to fund the kind of research that made the first uses of the Melody® valve in the mitral position possible.

If you can help, please reach out. We’d love to hear from you.

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