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IU surgeon’s new device to combat deadly birth defect earns NIH support for further testing


Mark Rodefeld, M.D., an associate professor of surgery at the IU School of Medicine, will use funding from the National Institutes of Health’s National Heart, Lung, and Blood Institute to further develop a new type of blood pump that uses a spinning disk to pull blood from the veins and push it into the arteries of children and adults born with only one functioning heart ventricle.

Currently only 50 percent to 70 percent of infants born with univentricular circulation survive the three open-heart surgeries required in the most common treatment, the Fontan procedures. The cost of the first few months of intensive care hospitalization for an infant born with the defect often exceeds $1 million. In addition, those fortunate to survive face lifelong disability with no comprehensive therapeutic treatment.

Rodefeld said the grant will support development of the viscous impeller pump through animal testing – one of the requisite phases prior to human trials – Food and Drug Administration approval and commercial development.

“It’s a completely new device, unlike any other that exists, so we expect the burden of proof to be high,” Rodefeld said. “But we believe that in patients with univentricular Fontan circulations, young and old, this safe, simple and reliable method to augment blood flow will address their unresolved health needs.”

No artificial blood pump currently exists that can provide the necessary low pressure support in the four-way flow system that is surgically constructed in patients with single ventricle heart disease to reach a final circulation known as Fontan circulation. Patients with univentricular circulations have a single effective ventricle that must pump blood to the body, and then to the lungs, in one cycle. Blood flow to the lungs has no dedicated power source, the single ventricle is overworked, and patients are susceptible to serious complications.

“Since there is no right-sided ventricular power source, blood flow back to the heart is profoundly altered, which results in a less than optimal filling of the single working ventricle,” Rodefeld said. “We can augment blood flow in the right-sided circulation, reproducing the more stable, normal two-ventricle physiology.”

The pump would be implanted into a four-way intersection where the body’s two central veins, the superior and inferior vena cavae, join the right and left pulmonary arteries. It uses an expandable spinning disk that provides multi-directional flow capability and would be implanted with the use of a catheter, then powered by a magnetic coupling.

In September 2009, IU’s Research and Technology Corp. entered into a memorandum of understanding with Rose-Hulman Institute of Technology’s Rose-Hulman Ventures to develop a prototype of the pump invented by Rodefeld and Purdue University School of Mechanical Engineering Professor Steven Frankel.

The goal is to now demonstrate a working rotary disk pump in an animal model that supports univentricular circulation at the required pressure, with clinical studies in humans to hopefully follow.