FDAnews Device Daily Bulletin

DYNATEK'S COMPLETES COATING DURABILITY TEST FOR DRUG ELUTING STENTS

May 4, 2006
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Springfield, Mo.-based Dynatek Laboratories has completed its first contract coating durability test for drug-eluting stents using its patent pending coating durability tester, the company announced. The test characterized coating durability for FDA submission and provided real-time evaluation of particulate loss from the drug-eluting stents in a dynamic, pulsatile environment, the company said.

Dynatek's coating durability testing services use laser particle counting technology to provide chronic coating durability data intended to satisfy FDA requirements such as those recommended in the agencys's guidance: "Non-Clinical Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems."

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.