PediaFlow® VAD

WorldHeart, in conjunction with a consortium consisting of the University of Pittsburgh, Children's Hospital of Pittsburgh, Carnegie Mellon University, and Launchpoint Technologies, Inc. have been developing the PediaFlow® VAD, a small magnetically levitated, rotary pediatric VAD. The PediaFlow® VAD is intended for use in pediatric patients.

The PediaFlow® VAD has evolved through a series of prototype designs of decreasing size and enhanced efficiency. The most recent design is comparable to the size of a AA battery.

The PediaFlow® VAD has demonstrated biocompatibility in chronic animal implants and laboratory tests, including low levels of hemolysis (breakdown of red blood cells), fibrinogen and platelet activation. Currently in the final stages of development, the PediaFlow® VAD is being assembled for preclinical verification testing in preparation for an NIH-sponsored clinical trial.

In February 2011, the FDA granted "Humanitarian Use Device" (HUD) designation for the PediaFlow® VAD. The HUD designation is given to devices that are intended to benefit patients with conditions that affect fewer than 4,000 patients per year. Under the HUD designation, manufacturers are required to demonstrate safety and the probable benefit of their device, but are not required to demonstrate efficacy.