Coating durability testing performed by Dynatek Laboratories allows for characterization of coatings on drug-eluting and other coated stents. Coating durability testing is recommended in the FDA Guidance for Industry, and is included in the current AAMI/ISO and ASTM draft standards. This testing is performed in a dynamic, pulsatile, temperature-controlled environment that represents the radial loading experienced by the stent in vivo. In addition, coating durability testing adds the capability of detecting particles that are shed from the stent during testing. Detection of particles can be performed in real-time, at predetermined intervals, or at the end of testing. Data gathered from coating durability testing can be readily evaluated against U.S. Pharmacopeia Standard <788>.
To learn more about coating durability testing, or to determine if coating durability testing is relevant to your device, contact us by phone at 1.800.325.8252, email us at testing@dynatekdalta.com, or complete our Contact Us form.
