PediaFlow® VAD

Need for the PediaFlow®

Pediatric Heart Failure in America

• Greater than 35,000 babies are born each year with congenital heart defects
• During the 1st critical year of life, 25% (~9,000) require invasive treatment
  • Phased corrective surgery and/or heart transplant: ~6 months
• 5,000-6,000 die from complications or from waiting for a suitable donor (> 50% of those on HTx list)

Need and Impact of the PediaFlow® VAD

• At least 20% (~1800) of these deaths can be prevented
• Another 20% (~1800) may have better outcomes and a better life going forward with reduced complications using this therapy/li>
• While numbers are small (~3600 potential patients/yr in US), the impact on the intended patient population is significant

Existing mechanical circulatory support technology is inadequate

• '60s technology, ECMO (Extra-Corporeal Membrane Oxygenation) is being used beyond its designed-for capabilities (see figure)
  • Presently the mainstay of mechanical circulatory support for infants and children
  • Not suitable for longer-term support (A few days use at most)
  • Extra-corporeal pneumatic blood pump available to keep babies alive
• Mortality and complications on ECMO and existing blood pumps remainhigh (as tabulated below that summarizes the experience of one of the leading pediatric heart centers in the United States: the Children's Hospital of Pittsburgh of the University of Pittsburgh Medical Center)

The photo below shows a child (upper left) being
supported by the ECMO (foreground)