Bringing Innovation to Growing Hearts

Because some children are treated with adult-sized medical devices, device makers are stepping up to help clinicians produce better outcomes. Dr. Mark Carlson, chief medical officer at St. Jude Medical, talks about innovations that are helping young heart patients grow up healthy.

Each year, more than 1 million babies are born worldwide with a congenital heart defect. Yet many pediatric patients are treated with adult-sized devices, which may not be optimal. Pediatric cardiologists, the U.S. Food & Drug Administration (FDA) and medical device makers have long recognized the need for solutions and educational resources to support pediatric patients.

St. Jude Medical has worked with FDA in recent years to explore and develop safe and effective medical devices to fit children's growing hearts. This spring, calling on manufacturers, clinicians and academics, FDA provided guidance asking for collaborative ways to address the challenges presented by pediatric patients and improve medical product research in children.

One example is our new HALO clinical trial. This U.S. investigational study is FDA-approved to evaluate the use of the country's smallest investigational pediatric mechanical heart valve designed specifically for infants. Already, three pediatric patients have successfully been implanted within the clinical trial. With the device in place, they will have a solution now and will be considered for traditional valves that are more appropriate as their bodies mature.

St. Jude Medical invests in advanced training for physicians in pediatric cardiology. We support future generations of health care providers through a multitude of fellows programs with academic institutions throughout the world, and foster other development opportunities aimed at optimizing outcomes for patients with current, evolutionary and revolutionary technologies.

Families dealing with congenital heart defects also want and need more educational resources. We've partnered with organizations like the non-profit Mended Little Hearts on the creation of important resources that will provide awareness and advocacy. One new tool is the Mended Little HeartGuide, a website with accurate and reliable information and much-needed support and educational resources for families of children affected by congenital heart disease. With efforts like these, St. Jude Medical is bringing our commitment to this critical area of health care into even sharper focus. To learn more, visit SJM.com/WeHeartKids.

ST. JUDE MEDICAL is a market leader in the research, design and development of electrophysiology and interventional cardiology solutions for pediatric patients worldwide. As a global medical device manufacturer, we are dedicated to transforming the treatment of some of the world's most expensive epidemic diseases by developing cost-effective medical technologies that save and improve lives. For more information, please visit SJM.com or follow us on Twitter @StJudeMedical.

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