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PMID: 40926069 Published · ppublish English Journal Article

Optimized FDA Blood Pump: A Case Study in System-Level Customized Ventricular Assist Device Designs.

Annals of biomedical engineering ·Vol. 53 ·No. 11 ·2025-11-00 ·Pages 2828-2844

Yıldırım C, Uçak K, Madayen A, Gölcez T, Ertürk H, Baran ÖU, Pekkan K

Abstract

The design and development of ventricular assist devices have heavily relied on computational tools, particularly computational fluid dynamics (CFD), since the early 2000s. However, traditional CFD-based optimization requires costly trial-and-error approaches involving multiple design cycles. This study aims to propose a more efficient VAD design and optimization framework that overcomes these limitations. We developed a system- and component-level ventricle assist device optimization approach by coupling a lumped parameter cardiovascular physiology model with parametric turbomachinery, volute design, and blade path generation packages. The framework incorporates pump hydrodynamic losses and is validated against experimental data from six distinct blood pump designs and CFD simulations. The optimization framework allows for the specification of both physiology-related and device-related objective functions to generate optimized blood pump configurations over a large parameter space. The optimization was applied to the U.S. Food and Drug Administration (FDA) benchmark blood pump as the baseline design. Results showed that an optimized FDA pump, maintaining the same cardiac output and aortic pressure, achieved a ~ 32% reduction in blade tip velocity compared to the baseline, resulting in an ~ 88% reduction in hemolysis. Additionally, an alternative design with a 40% reduction in blood-wetted area was generated while preserving the baseline pressure and flow. The proposed optimization framework improves device development efficiency by shortening the design cycle and enabling hydrodynamically optimized pumps that perform well across diverse patient hemodynamics. The optimized pump designs are available as open-source resources for further research and development.

Keywords
Benchmark devices Cardiovascular engineering Computational fluid dynamics FDA blood pump Lumped parameter modeling Optimization Ventricle assist devices
MeSH Terms
Heart-Assist Devices Models, Cardiovascular Humans United States Food and Drug Administration United States Prosthesis Design Hydrodynamics
Authors & Affiliations
7 authors, click to expand affiliations / ORCID
Yıldırım Canberk
Department of Biomedical Engineering, Koc University, 34060, Istanbul, Turkey.
Uçak Kağan
Department of Mechanical Engineering, Koc University, Rumeli Feneri Campus, Sarıyer, 34450, Istanbul, Turkey.
Madayen Ali
Department of Mechanical Engineering, Middle East Technical University, 06800, Ankara, Turkey.
Gölcez Tansu
Department of Biomedical Engineering, Koc University, 34060, Istanbul, Turkey.
Ertürk Hakan
Department of Mechanical Engineering, Bogazici University, 34342, Istanbul, Turkey.
Baran Özgür Uğraş
Department of Mechanical Engineering, Middle East Technical University, 06800, Ankara, Turkey.
Pekkan Kerem ORCID
Department of Mechanical Engineering, Koc University, Rumeli Feneri Campus, Sarıyer, 34450, Istanbul, Turkey. [email protected].
Article Info
Journal
Annals of biomedical engineering
Abbr.
Ann Biomed Eng
ISSN
1573-9686
Published
2025-11-00
Epub
2025-00-09
Pages
2828-2844
Language
English
Region
United States
NLM ID
0361512
Grants
HORIZON EUROPE European Innovation Council · HeartWise 101214454
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