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Detailed analysis of polymer response to delivery balloon expansion of drug-eluting stents versus bare metal stents.

Publication ,  Journal Article
Denardo, SJ; Carpinone, PL; Vock, DM; Tcheng, JE; Phillips, HR; Willenberg, BJ; Batich, CD; Pepine, CJ
Published in: EuroIntervention
July 2013

AIMS: We sought to describe the response of the polymer surface of drug-eluting stents (DES) to delivery balloon expansion, including quantitation of any resulting detached microparticles. METHODS AND RESULTS: We expanded the US Food and Drug Administration (FDA)-approved first- and second-generation DES in a vacuum filtration system and used optical and scanning electron microscopy to image the polymer surface, filters and delivery balloons. DES were expanded under a range of conditions, from in vitro conditions used for FDA regulatory submissions to human in vivo conditions. Dispersive Raman spectroscopy was used for definitive identification of microparticles. All polymer surfaces were topographically disturbed over an average of 4.6%-100% of the surface area imaged. Disturbances ranged from deformation (including peeling) to complete delamination. The dimensions of detached microparticles were 2-350 μm. The extent and nature of surface disturbances and microparticles were primarily a function of polymer composition (p<0.001 for 8/10 disturbance types/locations) and were independent of expansion condition (p=0.100 to 0.989 for 9/10 disturbance types/locations). CONCLUSIONS: Balloon expansion of first- and second-generation DES disturbs the polymer surface and can cause detachment of microparticles; each is functionally related to the specific polymer but not to expansion condition. Disturbance "roughness" and detached microparticles may contribute to DES limitations.

Duke Scholars

Published In

EuroIntervention

DOI

EISSN

1969-6213

Publication Date

July 2013

Volume

9

Issue

3

Start / End Page

389 / 397

Location

France

Related Subject Headings

  • Surface Properties
  • Stents
  • Spectrum Analysis, Raman
  • Prosthesis Failure
  • Prosthesis Design
  • Pressure
  • Polymers
  • Particle Size
  • Optical Imaging
  • Microscopy, Electron, Scanning
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Denardo, S. J., Carpinone, P. L., Vock, D. M., Tcheng, J. E., Phillips, H. R., Willenberg, B. J., … Pepine, C. J. (2013). Detailed analysis of polymer response to delivery balloon expansion of drug-eluting stents versus bare metal stents. EuroIntervention, 9(3), 389–397. https://doi.org/10.4244/EIJV9I3A62
Denardo, Scott J., Paul L. Carpinone, David M. Vock, James E. Tcheng, Harry R. Phillips, Bradley J. Willenberg, Christopher D. Batich, and Carl J. Pepine. “Detailed analysis of polymer response to delivery balloon expansion of drug-eluting stents versus bare metal stents.EuroIntervention 9, no. 3 (July 2013): 389–97. https://doi.org/10.4244/EIJV9I3A62.
Denardo SJ, Carpinone PL, Vock DM, Tcheng JE, Phillips HR, Willenberg BJ, et al. Detailed analysis of polymer response to delivery balloon expansion of drug-eluting stents versus bare metal stents. EuroIntervention. 2013 Jul;9(3):389–97.
Denardo, Scott J., et al. “Detailed analysis of polymer response to delivery balloon expansion of drug-eluting stents versus bare metal stents.EuroIntervention, vol. 9, no. 3, July 2013, pp. 389–97. Pubmed, doi:10.4244/EIJV9I3A62.
Denardo SJ, Carpinone PL, Vock DM, Tcheng JE, Phillips HR, Willenberg BJ, Batich CD, Pepine CJ. Detailed analysis of polymer response to delivery balloon expansion of drug-eluting stents versus bare metal stents. EuroIntervention. 2013 Jul;9(3):389–397.

Published In

EuroIntervention

DOI

EISSN

1969-6213

Publication Date

July 2013

Volume

9

Issue

3

Start / End Page

389 / 397

Location

France

Related Subject Headings

  • Surface Properties
  • Stents
  • Spectrum Analysis, Raman
  • Prosthesis Failure
  • Prosthesis Design
  • Pressure
  • Polymers
  • Particle Size
  • Optical Imaging
  • Microscopy, Electron, Scanning