Stand with Us to Make a Difference Today!
In the United States, individuals born with single ventricle congenital heart disease (SVHD) and living with Fontan circulation face a significant challenge – there are currently no approved medications specifically designed to address their needs. However, there is a ray of hope on the horizon as the United States Food and Drug Administration (FDA) is actively evaluating the potential approval of Udenafil, a groundbreaking medication that has shown promise in enhancing exercise capacity for patients aged 12 and above with SVHD and Fontan circulation. This is a significant development, as Udenafil has the potential to become the sole medication available for this unique and deserving patient group.
The Fontan procedure, a surgical intervention performed on those with SVHD, reroutes blood flow in the heart, enabling individuals to survive with only one functional ventricle. While this procedure has improved outcomes for many, individuals with Fontan circulation often experience challenges in physical exertion, limiting their exercise capacity and overall quality of life. This is where Udenafil comes in, offering a glimmer of hope to those living with SVHD and Fontan circulation.
Udenafil, currently under FDA review, has shown promising results in clinical studies, demonstrating its ability to enhance exercise capacity among patients with SVHD and Fontan circulation. If approved, Udenafil will mark a groundbreaking milestone as the first-ever medication tailored to address the unique needs of this patient group.
We are at a crucial juncture where your support can make a significant impact. By joining us in advocating for the approval of Udenafil by the FDA, you can help ensure that individuals with SVHD and Fontan circulation finally have access to a medication that can improve their exercise capacity and enhance their overall quality of life. Together, we can make a difference and pave the way for better healthcare options for this underserved population.
Watch the Expert speak
Don’t miss out on the latest updates from Dr. David Goldberg, the co-Principal Investigator of the Fontan Udenafil Exercise Longitudinal Assessment (FUEL) Trial. Discover more about the promising treatment option by watching the replay of his presentation. Stay informed and be a part of this exciting development!
You Can Lend a Hand Too
Mended Hearts Central Ohio invites you to participate in a brief 2-3 minute survey, sharing your personal story with the FDA. We have prepared letter templates to assist you in expressing your experiences.
In the survey, we kindly request you to share your story and your child’s story with the FDA. Here are the topics you can address:
- Challenges faced by SVHD and Fontan circulation patients in managing their medication and treatment regimen.
- The emotional and psychological impact of living with a complex congenital heart condition on both the child and the family.
- The long-term effects of Fontan circulation on physical development and overall well-being.
- Access to specialized healthcare services, including cardiac specialists and support programs, for SVHD and Fontan circulation patients.
- Educational support and accommodations are needed for children with SVHD and Fontan circulation to thrive in school.
- The financial burden and insurance challenges faced by families of SVHD and Fontan circulation patients.
- The importance of continued research and advancements in treatment options for SVHD and Fontan circulation.
Please feel free to share your personal experiences and perspectives on any of these topics. Your insights will help improve understanding and support for the SVHD and Fontan circulation community.
Too Busy to Write? Make a Short Video
Join the cause and make a difference by creating a compelling video testimony! Show your support for making Udenafil available as a vital treatment option by recording a cellphone video lasting no more than 1 minute. Share your personal perspective on the significance of Udenafil in your life. To have your video submission forwarded to the FDA, kindly send it to (email) Your contribution can help shape the future of healthcare.