Biocompatibility assessment of the first generation PediaFlow pediatric ventricular assist device.

Artificial Organs
Carl A JohnsonWilliam R Wagner

Abstract

The PediaFlow pediatric ventricular assist device is a miniature magnetically levitated mixed flow pump under development for circulatory support of newborns and infants (3-15 kg) with a targeted flow range of 0.3-1.5 L/min. The first generation design of the PediaFlow (PF1) was manufactured with a weight of approximately 100 g, priming volume less than 2 mL, length of 51 mm, outer diameter of 28 mm, and with 5-mm blood ports. PF1 was evaluated in an in vitro flow loop for 6 h and implanted in ovines for three chronic experiments of 6, 17, and 10 days. In the in vitro test, normalized index of hemolysis was 0.0087 ± 0.0024 g/100L. Hemodynamic performance and blood biocompatibility of PF1 were characterized in vivo by measurements of plasma free hemoglobin, plasma fibrinogen, total plasma protein, and with novel flow cytometric assays to quantify circulating activated ovine platelets. The mean plasma free hemoglobin values for the three chronic studies were 4.6 ± 2.7, 13.3 ± 7.9, and 8.8 ± 3.3 mg/dL, respectively. Platelet activation was low for portions of several studies but consistently rose along with observed animal and pump complications. The PF1 prototype generated promising results in terms of low hemolysis and platelet ...Continue Reading

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Citations

Mar 8, 2012·Artificial Organs·Paul S Malchesky
Apr 23, 2014·Journal of Biomedical Materials Research. Part a·Megan A JamiolkowskiWilliam R Wagner
Apr 19, 2016·Artificial Organs·Salim E OliaMarina V Kameneva
Jul 27, 2017·Artificial Organs·Chris H H ChanCatherine A Thornton
Sep 27, 2018·Artificial Organs·Carl A JohnsonWilliam R Wagner
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Jun 4, 2019·Expert Review of Medical Devices·Deepika N Sarode, Shuvo Roy
Jan 3, 2012·Cardiovascular Engineering and Technology·Timothy M MaulUNKNOWN The Pediaflow Consortium
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Oct 13, 2011·ASAIO Journal : a Peer-reviewed Journal of the American Society for Artificial Internal Organs·Carl A JohnsonWilliam R Wagner
Mar 25, 2014·ASAIO Journal : a Peer-reviewed Journal of the American Society for Artificial Internal Organs·Venkat ShankarramanChristian A Bermudez

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