Friday, April 18, 2014
Melody Valve Petition
Dear Heart Friends:
It's time for all of us to work together. Lives are at stake! Signing a simple petition could be the difference between life and death. Are you willing to add your signature?
Many of you in the Heart World know that babies born with bad mitral valves are greatly at risk. To date, many children have benefitted from a special device known as a Melody® valve. This valve has been placed in babies and children in limited numbers because the device is not FDA approved.
This petition would allow for Medtronics, the company that produces the Melody valve® to work with the FDA to create a special valve for babies and children. The original use for the Melody valve® was not for it to be used in children, but the brilliant doctors at Boston Children's Hospital and elsewhere have been modifying the valve to save children's lives.
If the changes were made under ordinary circumstances, then it would take a while for new studies to be conducted and for the valve to be available to the babies and children who need them. This petition requests that the FDA and Medtronic work together to get the device to those who can benefit from them now, and ultimately to obtain humanitarian use approval of the device.
It will only take a minute of your time, but that one minute of time-well-spent could save a life. Will you sign the petition?
Will you share this with others? If so, today you will have done a good deed that could touch countless lives. Thank you!