In vitro and in vivo evaluation of the safety and stability of the TAXUS® Paclitaxel-Eluting Coronary Stent
| Autor: | Mark Boden, James J. Barry, Marlene Schwarz, Robert E. Richard, Barbara Huibregtse, Steve Kangas |
|---|---|
| Rok vydání: | 2009 |
| Předmět: |
Male
Materials science Drug-Related Side Effects and Adverse Reactions Paclitaxel medicine.medical_treatment Biomedical Engineering Biophysics Bioengineering engineering.material Iliac Artery Coronary Restenosis Biomaterials Gel permeation chromatography chemistry.chemical_compound Drug Stability Coating Coronary stent Ultimate tensile strength medicine Animals Equipment Safety biology Stent Drug-Eluting Stents Equipment Design biology.organism_classification Coronary Vessels Blood Vessel Prosthesis Equipment Failure Analysis Treatment Outcome chemistry Taxus engineering Rabbits Drug carrier Biomedical engineering |
| Zdroj: | Journal of Materials Science: Materials in Medicine. 20:1553-1562 |
| ISSN: | 1573-4838 0957-4530 |
| Popis: | Functional aspects of the styrene-b-isobutylene-b-styrene triblock copolymer (SIBS) which is incorporated into a drug-eluting stent (DES) coating are described. The SIBS copolymer is employed on the TAXUS Paclitaxel-Eluting Coronary Stent as a carrier for paclitaxel (PTx). Optical and scanning electron microscopic analysis of stents explanted from rabbit and porcine models after 2 years and 6 months, respectively, showed that the SIBS coating maintained physical integrity. Gel permeation chromatography (GPC) of the copolymer extracted from the coating verified that no polymer degradation occurred over the same period of time. The coating on TAXUS Stents was shown to maintain physical integrity after 400 million cycles of pulsatile or mechanical (tensile) fatigue, simulating 10 years real time use. Inspection of the samples compared to untested controls showed no change in the coating under these cyclic simulated conditions. Films prepared with the same formulation found on TAXUS Stents maintained mechanical strength and resistance throughout the time of testing. Intentional defects introduced into the stent coating were shown to have only a minimal impact on PTx release. These data support the suitability of the SIBS copolymer as a drug carrier for DES applications. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|
Full text from SpringerLink