AVAILABILITY:

WorldHeart's PediaFlow VAD is not currently available for sale or investigational use.

STATUS:

In 2007 and 2008, WorldHeart and its R&D consortium members for the PediaFlow VAD achieved several development milestones including acute and chronic animal trials with the two iterations of PediaFlow VAD prototypes. This set of milestones and ongoing work on the miniature PediaFlow VAD clinical prototype has laid the groundwork for the development of a prototype MiVAD pump in 2009.

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Overview

Levacor VAD™

MiVAD

How it Works Design Process PediaFlow VAD

Need for the PediaFlow PediaFlow Consortium Publications

Technologies

Minimally Invasive VAD (MIVAD)

PediaFlow VAD

The implantable pediatric PediaFlow VAD is intended for use for bridge to transplant or as a bridge to recovery in the neonate (newborn) to infant population. This fully magnetically levitated miniature rotary blood pump is being designed:

For use by newborns-2 yrs, 3-15 kg body weight
To provide 0.3 to 1.5 l/min of flow
To provide ~6 months support

The PediaFlow VAD has been developed since 2004 with support from the U.S. National Institutes of Health. It is one of two devices being designed and developed for such a young population.

The device has successfully been developed from concept to chronic animal trials leading to a clinical prototype. This prototype has been built and is now being tested. The device will be refined and combined with the Levacor VAD wearables and peripherals to comprise the clinical PediaFlow VAD system in preparation for clinical system design finalization, verification and validation, and manufacturing. These activities are anticipated to lead to a US IDE submission for a clinical trial.