The current status of the initiative (to our knowledge) is that Medtronic and doctors at Boston Children’s Hospital are working on an approach to the FDA, and plan to file soon for approval of the Melody® valve in the mitral position.
On March 28, 2014 we sent the following letter to the FDA, Medtronic, and doctors at Boston Children’s Hospital. Our goal was to let them know we’re here, we’re watching, and we support their efforts and prioritization of filing with the FDA with all due haste. And we wanted to put the FDA on notice that not only do citizens care about this issue, but a few dozen of them are alive because of the Melody®.
If you want to get a good sense of what we’re up to, read the letter below, and feel free to comment.