A Medical Device Daily
World Heart (Oakland, California) reported the success of an animal implant of a miniaturized, ventricular assist device (VAD) for pediatric patients.
The PediaFlow VAD is being developed to provide medium-term implantable circulatory support to patients from birth to 2 years of age with congenital or acquired heart disease. The company says that the PediaFlow design also is the platform for a future minimally invasive adult VAD, intended to meet a clinical need for earlier-stage heart failure patients.
The implant focused on initial biocompatibility and mechanical function under physiologic conditions. The company said that "encouraging" bench testing results led to the animal implant performed by Peter Wearden, MD, PhD, at the University of Pittsburgh Medical Center.
The PediaFlow is an implantable, magnetically levitated blood pump based on WorldHeart's proprietary rotary VAD MagLev technology used in its Levacor device. In its pediatric configuration, the device is designed to provide a flow rate from 0.3-1.5 L/min. Development is funded by the National Institutes of Health , involving a consortium that includes the University of Pittsburgh and World Heart.
Jal Jassawalla, WorldHeart president/CEO, said, "We are … excited about potential adaptation [of the Pediaflow] to a broad, adult population with less advanced heart failure. We believe that pump miniaturization will allow implantation of the adult configuration using minimally invasive surgical techniques. This represents a complementary addition to the existing Levacor device."
The company says that the Levacor is the only bearingless, fully magnetically levitated implantable centrifugal rotary pump with clinical experience. The device uses magnetic levitation to fully suspend the spinning rotor, its only moving part, inside a compact housing.