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Biomedical Engineering / Biomedizinische Technik

Joint Journal of the German Society for Biomedical Engineering in VDE and the Austrian and Swiss Societies for Biomedical Engineering and the German Society of Biomaterials

Editor-in-Chief: Dössel, Olaf

Editorial Board: Augat, Peter / Habibović, Pamela / Haueisen, Jens / Jahnen-Dechent, Wilhelm / Jockenhoevel, Stefan / Knaup-Gregori, Petra / Lenarz, Thomas / Leonhardt, Steffen / Plank, Gernot / Radermacher, Klaus M. / Schkommodau, Erik / Stieglitz, Thomas / Boenick, Ulrich / Jaramaz, Branislav / Kraft, Marc / Lenthe, Harry / Lo, Benny / Mainardi, Luca / Micera, Silvestro / Penzel, Thomas / Robitzki, Andrea A. / Schaeffter, Tobias / Snedeker, Jess G. / Sörnmo, Leif / Sugano, Nobuhiko / Werner, Jürgen /

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Volume 58, Issue 5

Issues

Volume 57 (2012)

Development of a sirolimus-eluting poly (l-lactide)/poly(4-hydroxybutyrate) absorbable stent for peripheral vascular intervention

Niels Grabow
  • Corresponding author
  • Institute for Biomedical Engineering, University of Rostock, University Medicine, Rostock, Germany
  • Email
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Carsten M. Bünger / Sabine Kischkel / J. Hinrich Timmermann
  • Institute for Biomedical Engineering, University of Rostock, University Medicine, Rostock, Germany
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Thomas Reske
  • Institute for Biomedical Engineering, University of Rostock, University Medicine, Rostock, Germany
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  • De Gruyter OnlineGoogle Scholar
/ David P. Martin / Simon F. Williams / Wolfgang Schareck / Katrin Sternberg
  • Institute for Biomedical Engineering, University of Rostock, University Medicine, Rostock, Germany
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Klaus-Peter Schmitz
  • Institute for Biomedical Engineering, University of Rostock, University Medicine, Rostock, Germany
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
Published Online: 2013-07-30 | DOI: https://doi.org/10.1515/bmt-2012-0050

Abstract

Fully absorbable drug-eluting stent platforms are currently entering the clinical arena for the interventional treatment of coronary artery disease. This new technology also holds potential for application in peripheral vascular settings. Our study reports on the development of a sirolimus- (SIR) eluting absorbable polymer stent made from a blend of poly(l-lactide) and poly(4-hydroxybutyrate) (PLLA/P4HB) for peripheral vascular intervention. Stent prototypes were laser-cut from PLLA/P4HB tubes (I.D.=2.2 mm, t=250 µm), spray-coated with different PLLA/P4HB/SIR solutions, and bench-tested to determine expansion properties, fatigue, trackability and in vitro drug release kinetics. The stent prototypes were expanded with a 5.0×20 mm balloon catheter, and exhibited a recoil of 3.6% upon balloon deflation. Stent collapse pressure of 0.4 bar (300 mm Hg) was measured under external pressure load. Sustained scaffolding properties were observed in vitro over 14 weeks of radial fatigue loading (50±25 mm Hg at 1.2 Hz). Trackability was demonstrated in bench tests with an 8 French contralateral introducer sheath. SIR release kinetics were adjusted over a broad range by varying the PLLA/P4HB ratio of the coating matrix. The newly developed absorbable SIR-eluting PLLA/P4HB stent successfully fulfilled the requirements for peripheral vascular intervention under in vitro conditions.

Keywords: biodegradation; collapse; laser machining; local drug delivery; mechanical properties; recoil

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About the article

Corresponding author: Niels Grabow, Institute for Biomedical Engineering, University of Rostock, University Medicine, Friedrich-Barnewitz-Str. 4, D-18119 Rostock, Germany, Phone: +49-381-54345-554, Fax: +49-381-54345-602, E-mail:


Received: 2012-12-17

Accepted: 2013-07-08

Published Online: 2013-07-30

Published in Print: 2013-10-01


Citation Information: Biomedizinische Technik/Biomedical Engineering, Volume 58, Issue 5, Pages 429–437, ISSN (Online) 1862-278X, ISSN (Print) 0013-5585, DOI: https://doi.org/10.1515/bmt-2012-0050.

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©2013 by Walter de Gruyter Berlin Boston. Copyright Clearance Center

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