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FDA Guidance

(Heart Valve · Oxygenator)

Definition

Testing Designed for
Regulatory Confidence

Artificial heart valves are among the most critical life-saving implants in cardiovascular medicine. Designed to restore proper blood flow and replace damaged native valves, they must perform flawlessly under continuous mechanical and biological stress. From durability and hydraulic efficiency to hemocompatibility and thrombogenicity, every aspect of valve performance directly impacts patient safety and long-term outcomes.

Oxygenators are critical components in extracorporeal circulation systems, responsible for performing the essential function of gas exchange — removing carbon dioxide and enriching blood with oxygen during life-saving procedures such as cardiopulmonary bypass and ECMO. Their performance directly impacts patient safety, surgical outcomes, and long-term recovery.

Overview

The Tests

Accelerated Wear

(Heart Valve)

Blood Cell Damage

(Oxygenator)

Calcification

(Heart Valve)

Computational Flow Field Assessment

(Heart Valve)

Dynamic Failure Mode

(Heart Valve)

Gas Exchange Performance

(Oxygenator)

Heat Exchanger Performance

(Oxygenator)

Hydrodynamic Performance 

(Heart Valve)

Particle Image Velocimetry (PIV) 

(Heart Valve)

Pressure Drop 

(Oxygenator)

Steady Backflow Leakage

(Heart Valve)

Steady Forward Flow

(Heart Valve)