Engineering Solutions for evaluating durability and Enhancing Safety of Coronary, Aortic, and Structural Heart Class III medical devices: A Comprehensive Framework

Authors: Somashekharayya Hiremath

DOI: https://doi.org/10.5281/zenodo.14774310

Short DOI: https://doi.org/g83n27

Country: United States

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Abstract: Durability testing for Coronary, Aortic, and Structural Heart (Cardiovascular) Class III medical devices (implants), such as heart valves and stents, is critical for ensuring patient safety and device reliability. The mechanical failures and associated complications in the Coronary, Aortic, and Structural Heart Class III devices can lead to significant clinical consequences, including reduced cardiac function, reintervention, or even death. This paper explores the challenges associated with Coronary, Aortic, and Structural Heart Class III medical device durability, focusing on engineering methods and test approaches such as fatigue-to-fracture testing, bench modeling, and computational modeling. By understanding and implementing these methods, the medical device industry can improve device design, enhance patient safety, and meet regulatory standards effectively.

Keywords: Class III Medical Devices, Implant Durability, Fatigue-to-Fracture Testing, Heart Valves, Structural Integrity Testing, Cardiovascular, Coronary Devices, Computational Modeling, Bench Testing, Patient Safety, Engineering Methods.

Paper Id: 232079

Published On: 2019-11-12

Published In: Volume 7, Issue 6, November-December 2019

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