In 1995, a group at Baylor College of Medicine started to develop the NEDO biventricular assist device (BVAD) using two Gyro permanently implantable (PI) centrifugal pumps. This pump consists of a sealless pump housing and an impeller supported with a double pivot bearing. In May 2001, an RPM dynamic suspension system (RPM-DS) for the impeller was developed to improve durability and antithrombogenicity without a complex magnetic suspension system. From March 2000 to March 2002, eight BVAD bovine experimental studies were performed for more than 1 month. Two pumps were implanted in two cases without the RPM-DS (group A) and in six cases with the RPM-DS (group B). In group A, the survival period was 45 and 50 days. The primary reason for termination was an increase in the requiring power, which was related to deposition of white thrombus on the bottom bearing. In group B, the survival period was 37, 48, 51, 60, 80, and 90 days. The reasons for termination were not related to thrombus formation. No thrombus was observed in the pumps except for one right pump. In that experiment, the thrombus formation may have occurred when that pump had a low flow rate at a level of 1 L/min for 6 hr. These studies demonstrate the apparent antithrombogenic effect of RPM-DS. The NEDO BVAD is ready to move into a 3-month preclinical system evaluation.
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