Improving hydraulic performance of the left atrial assist device using computational fluid dynamics.

Background: The left atrial assist device (LAAD) is a novel continuous-flow pump designed to treat patients with heart failure with preserved ejection fraction, a growing type of heart failure, but with limited device-treatment options. The LAAD is implanted in the mitral plane and pumps blood from the left atrium into the left ventricle. The purpose of this study was to refine the initial design of the LAAD, using results from computational fluid dynamics (CFD) analyses to inform changes that could improve hydraulic performance and flow patterns within the LAAD.

Feasibility of an implantable bioreactor for renal cell therapy using silicon nanopore membranes.

The definitive treatment for end-stage renal disease is kidney transplantation, which remains limited by organ availability and post-transplant complications. Alternatively, an implantable bioartificial kidney could address both problems while enhancing the quality and length of patient life. An implantable bioartificial kidney requires a bioreactor containing renal cells to replicate key native cell functions, such as water and solute reabsorption, and metabolic and endocrinologic functions.

A Critical Comparison of Comparators Used to Demonstrate Credibility of Physics-Based Numerical Spine Models.

The ability of new medical devices and technology to demonstrate safety and effectiveness, and consequently acquire regulatory approval, has been dependent on benchtop, in vitro, and in vivo evidence and experimentation. Regulatory agencies have recently begun accepting computational models and simulations as credible evidence for virtual clinical trials and medical device development. However, it is crucial that any computational model undergo rigorous verification and validation activities to attain credibility for its context of use before it can be accepted for regulatory submission.

Characterization and Development of Universal Ventricular Assist Device: Computational Fluid Dynamics Analysis of Advanced Design.

We are developing a universal, advanced ventricular assist device (AVAD) with automatic pressure regulation suitable for both left and right ventricular support. The primary goal of this computational fluid dynamics (CFD) study was to analyze the biventricular performance of the AVAD across its wide range of operating conditions. An AVAD CFD model was created and validated using in vitro hydraulic performance measurements taken over conditions spanning both left ventricular assist device (LVAD) and right ventricular assist device (RVAD) operation.

Computational Fluid Dynamics Model of Continuous-Flow Total Artificial Heart: Right Pump Impeller Design Changes to Improve Biocompatibility.

Cleveland Clinic is developing a continuous-flow total artificial heart (CFTAH). This novel design operates without valves and is suspended both axially and radially through the balancing of the magnetic and hydrodynamic forces. A series of long-term animal studies with no anticoagulation demonstrated good biocompatibility, without any thromboemboli or infarctions in the organs.