Development of DexAide right ventricular assist device: update II.
The DexAide right ventricular assist device (RVAD) is a magnetically and hydrodynamically levitated implantable centrifugal pump. Recent progress includes 1) redesign of the inflow/outflow conduits, which yielded two successful 3-month experiments, 2) development of alternative journal bearing materials, and 3) completion of an 18-month duration of in vitro endurance testing. Verification testing of the RVAD electronics has been completed, and a prototype biventricular assist device (BVAD) system has been tested. Acute DexAide/CorAide BVAD implantations via median sternotomy in two calves documented BVAD control algorithms and anatomical fit. A drug-induced chronic calf heart failure model, currently under development in our laboratory, resulted in a successful BVAD implantation in a calf with heart failure. Our future plans are to complete in vitro and in vivo validation of alternative bearing materials, perform preclinical DexAide in vivo and in vitro reliability studies, and obtain Food and Drug Administration (FDA) approval for an Investigational Device Exemption to conduct a clinical pilot study. In conclusion, two successful 3 month in vivo experiments and an 18-month in vitro endurance test were completed. After final bearing material selection, the DexAide design will be "frozen" so that preclinical systems can be manufactured. BVAD experiments using a chronic heart failure model are in progress.
Fukamachi
Kiyotaka
K
Department of Biomedical Engineering, Lerner Research Institute, Cleveland Clinic, Cleveland, Ohio 44195, USA.
Saeed
Diyar
D
Massiello
Alex L
AL
Horvath
David J
DJ
Fumoto
Hideyuki
H
Horai
Tetsuya
T
Zahr
Roula
R
Shalli
Shanaz
S
Anzai
Tomohiro
T
Dessoffy
Raymond
R
Catanese
Jacquelyn
J
Chen
Ji-Feng
JF
Zhou
Qun
Q
Benefit
Stephen
S
Alfini
Sue
S
Golding
Leonard A R
LA
D000465:Algorithms; D000818:Animals; D002417:Cattle; D004195:Disease Models, Animal; D004867:Equipment Design; D006333:Heart Failure / Q000628:therapy*; D006353:Heart-Assist Devices; D006439:Hemodynamics