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

  • Niels Grabow EMAIL logo , Carsten M. Bünger , Sabine Kischkel , J. Hinrich Timmermann , Thomas Reske , David P. Martin , Simon F. Williams , Wolfgang Schareck , Katrin Sternberg and Klaus-Peter Schmitz
Published/Copyright: July 30, 2013

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.


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:

Partial financial support was provided from the European Regional Development Fund (ERDF) and the European Social Fund (ESF) within the joint research program between business and academia in Mecklenburg-Vorpommern, as well as from the German Ministry for Education (BMBF) for the collaborative research project “REMEDIS – Höhere Lebensqualität durch neuartige Mikroimplantate” within the program “Spitzenforschung und Innovation in den Neuen Ländern”.

Dipl.-Ing. Peter Behrens and Dr.-Ing. Wolfram Schmidt, Institute for Biomedical Engineering, University of Rostock, are gratefully acknowledged for sharing their expertise in stent testing.

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Received: 2012-12-17
Accepted: 2013-7-8
Published Online: 2013-07-30
Published in Print: 2013-10-01

©2013 by Walter de Gruyter Berlin Boston

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