A test method to evaluate chronic particulate generation from durable polymer stent coatings: a case study of CYPHER® sirolimus-eluting coronary stents

文献情報

出版日 2012-09-21

DOI 10.1039/C2AY25030F

インパクトファクター 2.896

著者

Judith H. Cohen, Karin M. Balss, Eugena Akerman-Revis, Mark Inderbitzen, James Lisk, Asha Marathe, Robert O'Brien, Elaine Pottinger-Cooper, William Rudd, Cheryl Wendel, George Papandreou, Cynthia A. Maryanoff

原文を見る

要旨

In order to predict the long term coating durability of drug-eluting stent (DES) products, we developed a new testing methodology using a novel mechanical tester to evaluate the potential of drug–polymer coatings to generate particles over time. The tester simulates the device radial fatigue expected during in vivo conditions due to expansion and contraction of the implanted vessel. Analysis by Scanning Electron Microscopy (SEM) of particulate collected via an in-line filtration system allows for evaluation of the chronic durability of DES polymer coatings. Data provided within show the durable polymer coating of CYPHER® Stents generates small amounts of particulates upon fatigue indicating coating integrity is maintained even when the DES system is subjected to expansion, deployment, and repetitive cycling modalities.

掲載誌

Analytical Methods

CiteScore: 5.1

自己引用率: 3.7%

年間論文数: 655

Analytical Methods welcomes early applications of new analytical and bioanalytical methods and technology demonstrating the potential for societal impact. We require that methods and technology reported in the journal are sufficiently innovative, robust, accurate, and compared to other available methods for the intended application. Developments with interdisciplinary approaches are particularly welcome. Systems should be proven with suitably complex and analytically challenging samples. We encourage developments within, but not limited to, the following technologies and applications: global health, point-of-care and molecular diagnostics biosensors and bioengineering drug development and pharmaceutical analysis applied microfluidics and nanotechnology omics studies, such as proteomics, metabolomics or glycomics environmental, agricultural and food science neuroscience biochemical and clinical analysis forensic analysis industrial process and method development