One (1) Heart Valve Accelerated Wear Durability Test System

The U.S. Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH), intends to purchase one (1) Heart Valve Accelerated Wear Durability Test System. This test system will be directly used in regulatory science research projects carried out by the Cardiac Device Flow Laboratory to develop and standardize non-clinical test methods for durability assessment of peripheral and cardiac valve devices.

Accelerated wear testing is a critical pre-market regulatory test requirement to evaluate the long-term durability and fatigue resistance of valvular devices, ensuring they can withstand millions of cardiac/respiratory cycles safely and effectively before use in animal studies and human subject trials.