Dynatek Laboratories Completes Drug Eluting Stent Coating Durability Test
Dynatek Laboratories has recently completed its first contract coating durability test for drug-eluting stents utilizing its patent pending Coating Durability Tester. The test characterized coating durability for FDA submission and provided the client with real-time evaluation of particulate loss from the drug-eluting stents in a dynamic, pulsatile environment. FDA Guidance for Industry entitled Non-Clinical Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems recommends evaluation of stent coating durability, and AAMI/ISO and ASTM committees are currently drafting standards for coating durability testing. Dynatek’s coating durability testing services utilize laser particle counting technology to provide chronic coating durability data intended to satisfy the requirements of current recommendations and upcoming standards.
Information on Dynatek’s coating durability testing and other testing services offered by Dynatek Laboratories can be found in our Products and in our Services area of our website.
Dynatek Laboratories has been the leader in accelerated in vitro testing of cardiovascular devices for over twenty years. When the need for in vitro testing of vascular stents arose, Dynatek met the need by offering the first stent testing in a dynamic, pulsatile environment. Having performed testing for many of the largest and smallest of companies, we are equipped to meet the testing needs of each individual client. As changes have occurred in stent materials, designs, locations of deployment, and standards for testing, and as more data has been collected concerning failure modes in vivo, Dynatek has modified its capabilities to address these changes.
At Dynatek Laboratories, we strive to meet the needs of each client. Whether the needs be straight-forward radial fatigue testing or complex bend testing, we work with each client individually to ensure that their needs are met.