Journal
BIOMEDICAL ENGINEERING-BIOMEDIZINISCHE TECHNIK
Volume 58, Issue 5, Pages 429-437Publisher
WALTER DE GRUYTER GMBH
DOI: 10.1515/bmt-2012-0050
Keywords
biodegradation; collapse; laser machining; local drug delivery; mechanical properties; recoil
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Funding
- European Regional Development Fund (ERDF)
- European Social Fund (ESF) within the joint research program between business and academia in Mecklenburg-Vorpommern
- German Ministry for Education (BMBF) for the collaborative research project REMEDIS - Hohere Lebensqualitat durch neuartige Mikroimplantate within the program Spitzenforschung und Innovation in den Neuen Landern
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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 mu m), 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 5.0x20 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.
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