PediaFlow - Treatment for Congenital Heart Failure in Infants and Children
Abstract
Congenital heart disease (CHD) is the most common type of birth defect and affects about 40,000 infants in the United States -- nearly 1% of all live births per year. It can be life-threatening or severely limit the lifespan of the child. Babies and young children with severe forms of the disease will require surgery to correct the defect or will be placed on a waiting list for a heart transplant. However, the number of available donor hearts is insufficient to meet the demand, and the waiting list continues to grow. Consequently, many children die while on the transplant list. The only lifesaving alternative to a transplant is a mechanical heart-assist pump. However, the only such device approved by the U.S. Food and Drug Administration (FDA) is based on 1970 s technology and has many deficits: it is too large to be implanted, prevents the child from going home, and has a very high risk of complications. In many cases, the parents and their doctors decide that the risks outweigh the potential benefits. This dire situation has motivated our research team over the past decade to develop a heart-assist pump designed specifically for children with severe heart failure. We have made great progress and have produced a miniature blood pump, named the PediaFlow, that is the size of an AA battery and meets all critical specifications: it is very efficient, reliable, and very “blood-friendly.” In order to make this technology available for children of Service members, and the general public, we need to complete additional steps that will permit us to obtain regulatory approval from the FDA for use in children. The 3-year project we propose here is to refine the current prototype PediaFlow pump (PF4) to make it ready for a clinical trial. We also will work to develop an external control unit and accessories (like a special bassinette that will let parents easily hold their infant child; or stuffed toy for toddlers). This will involve “human factors” design of the components – to maximize the quality of life and safety of the children and their parents. To assure that the implanted pump and controller are completely safe and will last a long time, we will conduct numerous tests as required by the FDA. Compared to the 1970 s-vintage heart-assist technology currently used to treat the most critically ill children, PediaFlow will provide a much more effective, much less invasive alternative. For example, by permitting these children to return home to recuperate, PediaFlow will dramatically improve their quality of life, and at a lower cost than keeping the children in a hospital. Successful completion of the proposed 3-year project will represent a critical milestone towards obtaining regulatory (FDA) approval and ultimately beginning a clinical trial with children. Relevance to Topic Area: This project addresses the treatment of Congenital Heart and specifically supports the Area of Encouragement designated “Development of approaches, including regenerative medicine, that provide structural support, restore native activity, allow for tissue growth, and prevent the need for reoperation.”
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Mar 10, 2021
- Source ID
- W81XWH2010387
Entities
People
- James F. Antaki
Organizations
- Cornell University
- United States Army