Journal
JOURNAL OF BIOMEDICAL MATERIALS RESEARCH PART A
Volume 92A, Issue 2, Pages 773-782Publisher
WILEY
DOI: 10.1002/jbm.a.32418
Keywords
vascular compatibility; poly(styrene-b-isobutylene-b-styrene); stability; mechanical properties
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The TAXUS (R) Express (2)(TM) Paclitaxel Eluting Coronary Stent System employs a coating consisting of the thermoplastic elastomer, poly(styrene-b-isobutylene-b-styrene; SIBS), selected for its drug-eluting characteristics, vascular compatibility, mechanical properties, and biostability. This study was conducted to evaluate the impact of different SIBS (17-51 mole % styrene) compositions on mechanical properties, chemical stability, and vascular compatibility. Mechanical property (stress-strain measurements) and stability studies were conducted on polymer films with five different styrene contents (17, 24, 32, 39, and 51 mole %). The ultimate tensile strength did not change significantly with composition, but the elongation at break decreased with increased styrene content. A pulsatile fatigue test further confirmed the mechanical stability of SIBS up to 39 mole %, styrene. The vascular compatibility of five different SIBS compositions was assessed using SIBS-only coated stents, in the coronary and carotid arteries in a porcine model Study. The stability of the vessel wall, rate/degree of endothelialization, inflammation, and thrombus at timepoints from 30 to 180 days were evaluated. The results confirm vascular compatibility over the range of 17-51 mole % styrene. (C) 2009 Wiley Periodicals, Inc. J Biomed Mater Res 92A: 773-782, 2010
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