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Coatings Ingredients
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Drug-Eluting Stent Tester -- Testing the Durability of Stent Coating

Published on 2005-07-21. Author : SpecialChem

SPRINGFIELD, MO -- Dynatek dalta Scientific Instruments announces the release of the world's first real-time Coating Durability Tester (CDT) to evaluate the durability of coatings on drug-eluting and other coated stents. The first client installation of the new CDT is scheduled for August 1, 2005. Orders are currently being taken for purchase of the CDT and for contract coating durability testing.

Building on proven accelerated fatigue testing technology, Dynatek's Coating Durability Tester adds to the trusted testing of the Large Vascular Prosthesis Testers (LVP) and Small Vascular Prosthesis Testers (SVP) by providing dynamic, real-time evaluation of stent coatings through laser particle counting technology.

Dynatek's CDT measures size and number of particles shed from each stent without the need for removal of the testing solution. This real-time particle counting allows the user to know precisely when stent shedding occurs. In addition, the CDT's unique bypass filtration system allows for removal of the filters without test interruption.

Similar to Dynatek's SVP and LVP, the CDT stresses the stent in a dynamic, pulsatile environment that causes expansion and contraction of the stent. This expansion and contraction adds confidence to the testing by stressing the coating in a manner representative of movement in a human vessel.

Dynatek's stent testing has shown to be highly predictive of clinical outcomes, and provides for representation of years of human (in vivo) life in only months of bench-top (in vitro) testing. Addressing concerns about the possibility of stent coating breaking off and collecting in small blood vessels, the CDT helps to ensure the safety and effectiveness of a stent prior to clinical use. In anticipation of upcoming FDA and ISO standards for testing of stent coating, Dynatek's CDT also provides a means by which the durability of the coating can be demonstrated to a regulatory committee.

Applications for the Coating Durability Tester include evaluation of small coated vascular stents, large coated vascular stents, bifurcated coated vascular stents, and non-vascular coated stents. In addition, the CDT may be modified to test other coated devices.

With over 20 years of experience, Dynatek leads the world in testing of cardiac and vascular devices. Dynatek's bench-top testing has consistently demonstrated the ability to predict clinical failures prior to clinical evaluation. This adds confidence to the safety and effectiveness of the tested product, and may prevent costly clinical failures.

From the introduction of the standard-setting M6 heart valve tester to the newly released Coating Durability Tester, Dynatek continually pushes forward with innovative thinking for custom-designed testing equipment and services. Dynatek's team specializes in developing testers and testing protocols designed for the specific needs of each client.

Source: Dynatek Dalta

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