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.

March 28, 2014

Omar Ishrak
Chairman and Chief Executive Officer
Medtronic
710 Medtronic Pwky NE LC -110
Minneapolis, MN 55432

Dear Omar,

We are parents of children who, as mitral valve disease threatened their lives, received Melody valves in their mitral positions. If it were just a few years ago—as you well know—there would have been no good options for them. Without the Melody, our kids’ chances for survival would be slim.

So thank you for the Melody valve. Because of the Melody, and the courage and innovation led by doctors at Boston Children’s Hospital, our children have a chance to not only survive but to thrive.

Our children were the trailblazers. They were the firsts to receive the Melody valve either at Boston Children’s or hospitals that have worked closely with Boston. It’s time, however, to move past trailblazer and Boston-innovation-centric use of the Melody, and make the Melody valve an accepted and FDA approved treatment for children with mitral valve disease.

We understand that the doctors at Boston Children’s Hospital are working with you to make physical modifications to the valve so it will work best for the mitral position, and to file an IDE with the FDA. The Melody has already saved lives. FDA approval will save many more.

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 quite a bit before being able to get replacement valve, but that they didn’t know how long she would make it 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 (besides some major gas!) has been thriving ever since.

We know too many similar stories. Parents will be told to keep their babies comfortable as they wait to die because the doctors don’t know the Melody is an option, or won’t act until it is approved for use in the mitral position. We are determined to help see this become reality.

Fortunately, it seems like great timing to file, since the CDRH recently released their strategic plan with the goals of decreasing IDE cycle and approval times, increasing the number of early feasibility/first-in-human IDE studies, and leaning towards post-market data collection when the benefits of earlier access to devices would benefit the patients. All seem to support the effort to approve the Melody valve.

As you might imagine, we see ourselves as more than simply interested parties in the progress of this initiative. We believe deeply in the importance of your work in conjunction with the doctors to make the necessary modifications to the Melody valve for the mitral position, and pursue expedited approval with the FDA for an indicated use.

To these ends, we ask the following. Please:

1. Work with the doctors at Boston Children’s Hospital energetically, proactively, with a true sense of urgency to make the necessary modifications to the valve, create a plan to file with the FDA, and execute the filing. This needs to be a priority.
2.  Establish a main point of contact to keep us informed of your plans and be responsive to any requests for updates or information.

Our intent is to create widespread and spirited public support for expedited approval of the Melody for mitral use. You’ll find that when you’re ready to file (which we expect will be with all due haste), you’ll have a group of citizens with compelling and newsworthy stories urging the FDA to say yes.

It’s also our request to collaborate with you to align our efforts in ways that will best support gaining approval. We are looking forward to working with you and your guidance to get the best outcome.

Shortly we’ll be launching a website to build awareness and public support. With the power of social media, the interconnectedness of the heart parent community, and our deep belief in the significance of getting the Melody approved for the mitral position, we believe we’ll have quite the impact.

Again, thank you for your mission, the Melody, and prioritizing the pursuit of approving the Melody for use in the mitral position for infants and children for whom there are no other options. We look forward to working with you and seeing the Melody approved.

Sincerely,

Mike and Erica Schultz, parents of Ari, age 2, Melody at 20 weeks. Ari is addicted to basketball and baseball. He is smart as a whip. Because of the Melody in the mitral position, Ari is alive and thriving.

Also on behalf of:

Glenn and Emily Duhe, parents of Allie, age 3 and a half, Melody at 9 months. She was failure to thrive and a very sick baby prior. After her Melody she was pink and smiling. Never thought we would have a happy thriving three year old. Because of the Melody in the mitral position, Allie is alive and thriving.

David and Kristi Ross, parents of Grace Ross, age 18 months, Melody at 15 months. Grace is a Daddy’s girl; she loves life (especially her dogs, and siblings). She blesses everyone around her with her infectious smile and personality. Because of the Melody in the mitral position, Grace Ross is alive and thriving.

Amanda and Shane Drause, parents of Gideon, age 3 months. Gideon’s Melody surgery was denied twice by the insurance company. They told us to get him a transplant. Now, Gideon gets his Melody tomorrow. He is a fun and happy baby. We look forward to an amazing future with him because of the Melody in the mitral position.

Thomas and Evelyn Robbins, parents of Alexander Vincent, age 2, Melody at 7 months. Alex is an energetic, playful 2 year old who always has a smile on his face. He loves his three siblings and his puppy, “Woo Woo.” Thanks to the Melody in the mitral position he is blessing lives and living his own to the fullest.

Benjamin and Margaret Narolis, parents of Logan, age 3 and a half, Melody at 16 months. He is an energetic little boy who loves and excels at preschool, as well as playing outside and with his train set. Because of the Melody in the mitral position, Logan is alive and thriving.

Robert and Heather Trucheon, parents of Chloe Mai, age 17 months, Melody at 10 weeks. Chloe is very passionate about music. Will climb anything and everything, and loves playing with her four siblings. Because of the Melody in the mitral position, Chloe Mai is alive and thriving.

Jenn Sawyer and Adam Howell, parents of Olivia, age 19 months, Melody at 7 months. Olivia is doing great and has been growing since her Melody placement a year ago. Because of the Melody in the mitral position, Olivia is alive and thriving.

Thomas and Jennifer Ascone, parents of Cooper, just shy of age 4, Melody valve at 2 and a half. Cooper is full of life and energy. He loves playing all sports and loves being a big brother to his twin sister and little brother. Because of the Melody in the Mitral position, Cooper is alive and thriving.

Chris and Ashley Miles, parents of Zuzu, age 13 months, Melody at 24 weeks. Zuzu is the embodiment of love and trust. She is always happy and giggly. Because of the Melody in the mitral position, Zuzu is alive and thriving.

Nick and Janelle Foligno, parents of Milana, age 5 months, Melody at 3 weeks. Milana is smiley and loves to play peek-a-boo. Because of the Melody in the Mitral position, Milana is alive and thriving.

Elisabeth and Bryan Hunter, parents of William St. George Hunter, age 28 months, Melody at 17 months. After struggling to gain just one pound in seven months due to an “impressively awful native valve”, George received his Melody and gained 7 pounds over the following three months. The Melody has already spared him one open-heart surgery. George is an absolute mischievous delight. Because of the Melody in the Mitral position, George is alive and thriving.

Kevin and Amie Helmick, parents of Preston, almost age 3, Melody at 23 months. Preston has the best spirit of anyone I’ve ever met, despite what he’s been through. Now, because of his improvement, he gets to share his life with a heart-healthy baby brother, due in July. This blessing needs to be shared with others that need it as well. Because of the Melody in the Mitral position, Preston is alive and thriving.

CC:

Michael Coyle
Executive Vice President and Group President, Cardiac and Vascular Group
Medtronic

John Liddicoat, MD
Senior Vice President
Medtronic

Rhonda Robb
Vice President and General Manager, Medtronic Catheter Based Therapies
Medtronic

Sitaram Emani, MD
Boston Children’s Hospital
Department of Cardiac Surgery

Audrey Marshall, MD
Boston Children’s Hospital
Department of Cardiology

Wayne Tworetzky, MD
Boston Children’s Hospital
Cardiology Research Center

James Lock, MD
Boston Children’s Hospital
Cardiology Research Center

Margaret A Hamburg, M.D.
Commissioner of Food and Drug
US Food and Drug Administration

Bram D. Zuckerman, MD
Director of Cardiovascular Devices
US Food and Drug Administration

Jeffery E. Shuren, M.D., J.D.
Director, Center for Devices and Radiological Health
US Food and Drug Administration