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Acute Particulate Evaluation

ASTM and ISO regulations require acute phase particulate testing of medical devices destined for human vasculature in order to assess safety, risk, and efficacy during tracking, deployment, and withdrawal.  We utilize a temperature-controlled positive-pressure flow loop with customizable deployment platform to simulate the vascular pathway your devices will travel for deployment.  In-line particle sensors provide a time course of particle sizes and counts throughout the sample run.  Collection of shed particles on the integrated filter membrane allow for subsequent SEM/EDX and/or FTIR analysis.  This approach allows manufacturers to know the precise particle contribution of their devices and deployment accessories.

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