Search Results - "Malinauskas, Richard A"

Physicochemical characterization and in vitro hemolysis evaluation of silver nanoparticles by Choi, Jonghoon, Reipa, Vytas, Hitchins, Victoria M, Goering, Peter L, Malinauskas, Richard A

“…Silver nanomaterials are increasingly being used as antimicrobial agents in medical devices. This study assessed the in vitro hemolytic potential of unbound…”
Get full text

Comparison of Two Platelet Activation Markers Using Flow Cytometry After In Vitro Shear Stress Exposure of Whole Human Blood by Lu, Qijin, Malinauskas, Richard A.

“…Platelet activation is the initiating step to thromboembolic complications in blood‐contacting medical devices. Currently, there are no widely accepted testing…”
Get full text

Use of the FDA nozzle model to illustrate validation techniques in computational fluid dynamics (CFD) simulations by Hariharan, Prasanna, D'Souza, Gavin A, Horner, Marc, Morrison, Tina M, Malinauskas, Richard A, Myers, Matthew R

“…A "credible" computational fluid dynamics (CFD) model has the potential to provide a meaningful evaluation of safety in medical devices. One major challenge in…”
Get full text

In Vitro Shear Stress-Induced Platelet Activation: Sensitivity of Human and Bovine Blood by Lu, Qijin, Hofferbert, Bryan V., Koo, Grace, Malinauskas, Richard A.

“…As platelet activation plays a critical role in physiological hemostasis and pathological thrombosis, it is important in the overall hemocompatibility…”
Get full text

Multilaboratory particle image velocimetry analysis of the FDA benchmark nozzle model to support validation of computational fluid dynamics simulations by Hariharan, Prasanna, Giarra, Matthew, Reddy, Varun, Day, Steven W, Manning, Keefe B, Deutsch, Steven, Stewart, Sandy F C, Myers, Matthew R, Berman, Michael R, Burgreen, Greg W, Paterson, Eric G, Malinauskas, Richard A

“…This study is part of a FDA-sponsored project to evaluate the use and limitations of computational fluid dynamics (CFD) in assessing blood flow parameters…”
Get more information

Analysis of Transitional and Turbulent Flow Through the FDA Benchmark Nozzle Model Using Laser Doppler Velocimetry by Taylor, Joshua O., Good, Bryan C., Paterno, Anthony V., Hariharan, Prasanna, Deutsch, Steven, Malinauskas, Richard A., Manning, Keefe B.

“…Transitional and turbulent flow through a simplified medical device model is analyzed as part of the FDA’s Critical Path Initiative, designed to improve the…”
Get full text

The effect of blood viscosity on shear‐induced hemolysis using a magnetically levitated shearing device by Krisher, James A., Malinauskas, Richard A., Day, Steven W.

“…Introduction Blood contacting medical devices, including rotary blood pumps, can cause shear‐induced blood damage that may lead to adverse effects in patients…”
Get full text

Effect of Temperature on Thrombogenicity Testing of Biomaterials in an In Vitro Dynamic Flow Loop System by Patel, Mehulkumar, Jamiolkowski, Megan A., Vejendla, Anjali, Bentley, Viviana, Malinauskas, Richard A., Lu, Qijin

“…To develop and standardize a reliable in vitro dynamic thrombogenicity test protocol, the key test parameters that could impact thrombus formation need to be…”
Get full text

Results of the Interlaboratory Computational Fluid Dynamics Study of the FDA Benchmark Blood Pump by Ponnaluri, Sailahari V., Hariharan, Prasanna, Herbertson, Luke H., Manning, Keefe B., Malinauskas, Richard A., Craven, Brent A.

“…Computational fluid dynamics (CFD) is widely used to simulate blood-contacting medical devices. To be relied upon to inform high-risk decision making, however,…”
Get full text

FDA Benchmark Medical Device Flow Models for CFD Validation by Malinauskas, Richard A, Hariharan, Prasanna, Day, Steven W, Herbertson, Luke H, Buesen, Martin, Steinseifer, Ulrich, Aycock, Kenneth I, Good, Bryan C, Deutsch, Steven, Manning, Keefe B, Craven, Brent A

“…Computational fluid dynamics (CFD) is increasingly being used to develop blood-contacting medical devices. However, the lack of standardized methods for…”
Get full text

An In Vitro Blood Flow Loop System for Evaluating the Thrombogenicity of Medical Devices and Biomaterials by Jamiolkowski, Megan A., Hartung, Matthew C., Malinauskas, Richard A., Lu, Qijin

“…A reliable in vitro dynamic test method to evaluate device thrombogenicity is very important for the improvement of the design and safety of blood-contacting…”
Get full text

Comparison of animal and human blood for in vitro dynamic thrombogenicity testing of biomaterials by Jamiolkowski, Megan A., Patel, Mehulkumar, Golding, Madelyn D., Malinauskas, Richard A., Lu, Qijin

“…Background To determine suitable alternatives to human blood for in vitro dynamic thrombogenicity testing of biomaterials, four different animal blood sources…”
Get full text

A CFD-based Kriging surrogate modeling approach for predicting device-specific hemolysis power law coefficients in blood-contacting medical devices by Craven, Brent A., Aycock, Kenneth I., Herbertson, Luke H., Malinauskas, Richard A.

“…Most stress-based hemolysis models used in computational fluid dynamics (CFD) are based on an empirical power law correlation between hemolysis generation and…”
Get full text

Platelet and leukocyte count assay for thrombogenicity screening of biomaterials and medical devices: Evaluation and improvement of ASTM F2888 test standard by Lu, Qijin, Nehrer, Joshua M., Li, Jiaming, Jamiolkowski, Megan A., Rinaldi, Jean E., Malinauskas, Richard A.

“…An appropriate preclinical thrombogenicity evaluation of a blood‐contacting device is important to reduce thrombosis and thromboembolism risks to patients. The…”
Get full text

Centrifugation assay for measuring adhesion of serially passaged bovine chondrocytes to polystyrene surfaces by Kaplan, David S, Hitchins, Victoria M, Vegella, Thomas J, Malinauskas, Richard A, Ferlin, Kimberly M, Fisher, John P, Frondoza, Carmelita G

“…A major obstacle in chondrocyte-based therapy for cartilage repair is the limited availability of cells that maintain their original phenotype. Propagation of…”
Get more information

Renal Toxicodynamic Effects of Extracellular Hemoglobin After Acute Exposure by Baek, Jin Hyen, Yalamanoglu, Ayla, Brown, Ronald P, Saylor, David M, Malinauskas, Richard A, Buehler, Paul W

“…Abstract Plasma hemoglobin (Hb) is elevated in some hematologic disease states, during exposures to certain toxicants, and with the use of some medical…”
Get full text

Verification Benchmarks to Assess the Implementation of Computational Fluid Dynamics Based Hemolysis Prediction Models by Hariharan, Prasanna, D'Souza, Gavin, Horner, Marc, Malinauskas, Richard A, Myers, Matthew R

“…As part of an ongoing effort to develop verification and validation (V&V) standards for using computational fluid dynamics (CFD) in the evaluation of medical…”
Get more information

Predicting Plasma Free Hemoglobin Levels in Patients Due to Medical Device–Related Hemolysis by Saylor, David M, Buehler, Paul W, Brown, Ronald P, Malinauskas, Richard A

“…Blood passage through medical devices can cause hemolysis and increased levels of plasma free hemoglobin (pfH) that may lead to adverse effects such as…”
Get full text

Preclinical Device Thrombogenicity Assessments: Key Messages From the 2018 FDA, Industry, and Academia Forum by jamiolkowski, megan a., snyder, trevor a., perkins, ina laura, malinauskas, richard a., lu, qijin

“…Device-related thrombosis and thromboembolic complications remain a major clinical concern and often impact patient morbidity and mortality. Thus, improved…”
Get full text

Effects of nanotopography on the in vitro hemocompatibility of nanocrystalline diamond coatings by Skoog, Shelby A., Lu, Qijin, Malinauskas, Richard A., Sumant, Anirudha V., Zheng, Jiwen, Goering, Peter L., Narayan, Roger J., Casey, Brendan J.

“…Nanocrystalline diamond (NCD) coatings have been investigated for improved wear resistance and enhanced hemocompatibility of cardiovascular devices. The goal…”
Get full text