Development of a Disposable Maglev Centrifugal Blood Pump Intended for One-Month Support in Bridge-to-Bridge Applications: In Vitro and Initial In Vivo Evaluation

MedTech Dispo, a disposable maglev centrifugal blood pump with two degrees of freedom magnetic suspension and radial magnetic coupling rotation, has been developed for 1‐month extracorporeal circulatory support. As the first stage of a two‐stage in vivo evaluation, 2‐week evaluation of a prototype MedTech Dispo was conducted. In in vitro study, the pump could produce 5 L/min against 800 mm Hg and the normalized index of hemolysis was 0.0054 ± 0.0008 g/100 L. In in vivo study, the pump, with its blood‐contacting surface coated with biocompatible 2‐methacryloyloxyethyl phosphorylcholine polymer, was implanted in seven calves in left heart bypass. Pump performance was stable with a mean flow of 4.49 ± 0.38 L/min at a mean speed of 2072.1 ± 64.5 rpm. The maglev control revealed its stability in rotor position during normal activity by the calves. During 2 weeks of operation in two calves which survived the intended study period, no thrombus formation was seen inside the pump and levels of plasma free hemoglobin were maintained below 4 mg/dL. Although further experiments are required, the pump demonstrated the potential for sufficient and reliable performance and biocompatibility in meeting the requirements for cardiopulmonary bypass and 1‐week circulatory support.