title: Development of a sirolimus-eluting poly (L-lactide)/poly(4-hydroxybutyrate) absorbable stent for peripheral vascular intervention.
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.
authors.forename: Niels
authors.initials: N
authors.lastname: Grabow
authors.forename: Carsten M
authors.initials: CM
authors.lastname: Bünger
authors.forename: Sabine
authors.initials: S
authors.lastname: Kischkel
authors.forename: J Hinrich
authors.initials: JH
authors.lastname: Timmermann
authors.forename: Thomas
authors.initials: T
authors.lastname: Reske
authors.forename: David P
authors.initials: DP
authors.lastname: Martin
authors.forename: Simon F
authors.initials: SF
authors.lastname: Williams
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Schareck
authors.forename: Katrin
authors.initials: K
authors.lastname: Sternberg
authors.forename: Klaus-Peter
authors.initials: KP
authors.lastname: Schmitz
mesh_terms: D020341:Absorbable Implants; D000818:Animals; D004343:Drug Implants / Q000008:administration & dosage / Q000138:chemical synthesis*; D054855:Drug-Eluting Stents; D019544:Equipment Failure Analysis; D006083:Graft Occlusion, Vascular / Q000209:etiology / Q000517:prevention & control*; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage; D016491:Peripheral Vascular Diseases / Q000628:therapy*; D011091:Polyesters / Q000138:chemical synthesis*; D011474:Prosthesis Design; D020123:Sirolimus / Q000008:administration & dosage*; D000094122:Polyhydroxybutyrates
chemical_list: D004343:Drug Implants; D007166:Immunosuppressive Agents; D011091:Polyesters; D020123:Sirolimus; C523788:poly(3-hydroxybutyrate-co-lactide); D000094122:Polyhydroxybutyrates