Acute Particulate Matter Evaluation by ProtomedLabs – The ASTM International has released a new standard to measure the total cumulative number of particulate matter released from medical devices during simulated use, ASTM F2743-11 – Standard Guide for Coating Inspection and Acute Particulate Characterization of Coated Drug-Eluting Vascular Stent Systems. Particulate matter can be generated from degradation or delamination of coated devices such as stent delivery systems, drug-eluting stents and hydrophilic coated catheters. Introduction of particulate matter in the blood stream during acute clinical use may present an embolic risk to the patient. In order to evaluate the amount of particulate matter generated from coated medical devices, PROTOMEDLABS and MACHINE SOLUTIONS INC. have jointly developed A NEW TEST METHOD based on the ASTM F2743 test standard recommendations, combining a NEW CONTINUOUS FLOW IN-LINE PARTICULATE MATTER and the IDTE 2000

 

[bouton color=”orange”]Test Method Details[/bouton]