A Rendering of a PediaFlow control unit prototype.

Infant heart-assist device gets new life with $4.7M grant

After being defunded by a company with rights to its intellectual property, development of a pediatric heart-assist device has been revived at Cornell with the help of a $4.7 million grant from the U.S. Department of Defense.

Development and preclinical validation of the PediaFlow heart-assist system will be led by James Antaki, the Susan K. McAdam Professor of Heart Assist Technology at Cornell’s Meinig School of Biomedical Engineering.

Various components of the PediaFlow infant heart-assist device.

PediaFlow is an alternative to a heart transplant for infants with congenital heart failure. The device is based on the world’s smallest magnetically levitated rotodynamic blood pump, which was invented by Antaki and colleagues. Implantation of the device – about the size of a AA battery – can potentially rehabilitate an infant’s heart by stimulating recovery of the muscle.

The system also includes a battery-operated external control unit and peripherals for diagnostics and maintenance.

Antaki began work on the device in 2002, when the National Institutes of Health (NIH) issued a call for proposals for pediatric circulatory support because none existed at the time. By 2013, Antaki had found a commercial partner for PediaFlow, as required by the NIH, and was ready to move the device into the next phase of development.

But the research came to an abrupt end when the partner was acquired by a company with no interest in pediatric heart pumps. The project was shelved and the government grant money that had been funding it was returned.

Antaki reluctantly turned his attention to other projects – until he was contacted by a woman asking to help her granddaughter, who needed a heart transplant.

“My first reaction was, ‘How can I possibly help you? I’m just a professor of biomedical engineering,’” said Antaki, “but then it occurred to me that if we were still doing the PediaFlow project, then I really could help.”

Antaki did some research into the Bayh-Dole Act, which allows federal contractors who acquire ownership of inventions made with federal funding to retain that ownership. Two large government contracts from the NIH had made the PediaFlow device possible, yet a private corporation had acquired the license for the technology for the purpose of preventing anyone from developing it further.

In March 2016, Antaki wrote to the act’s sponsor, former Republican Sen. Robert Dole of Kansas, who had taken a position at a Washington, D.C., law firm following his retirement from the Senate. Dole arranged an introduction to intellectual property lawyers from the firm; by November 2018, Antaki had won the right to develop the PediaFlow.

The grant awarded by the U.S. Department of Defense’s Peer Reviewed Medical Research Partnership is allowing Antaki to reassemble the team of collaborators that designed the PediaFlow’s original prototypes.

Said Antaki: “It is a new lease on life for this device for children who have no other alternative.”

Chris Dawson is a writer for the College of Engineering.

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