Tissue biocompatibility of new biodegradable drug-eluting stent materials |
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Authors: | Ilkka Uurto Andres Kotsar Taina Isotalo Joonas Mikkonen Paula M. Martikainen Minna Kellomäki Pertti Törmälä Teuvo L. J. Tammela Martti Talja Juha-Pekka Salenius |
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Affiliation: | Department of Surgery, Satakunta Central Hospital, Pori, Finland. ilkka.uurto@uta.fi |
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Abstract: | Drug-eluting stents are a recent innovation for endovascular and endourethral purposes. The aim of this study was to assess the biocompatibility of new biodegradable drug-eluting stent materials in vivo. Rods made of SR-PLDLA (self-reinforced poly-96l,4d-lactic acid) covered with P(50l/50d)LA and rods made of 96l/4D SR-PLA and covered with P(50l/50d)LA including indomethacin 3.3 μg/mm2 or dexamethasone 1.5 μg/mm2, were inserted into the dorsal muscles of 20 rabbits serving as test animals. Rods made of silicone and organotin-positive polyvinylchloride were used as negative and positive controls. The animals were sacrificed after 1 week, 1 month, 2 months or 4 months. Histological changes attributable to the operative trauma were seen in all specimens at 1 week and 1 month. At 2 months both dexamethasone and indomethacin induced less fibrosis than the plain SR-PLDLA covered with P(50l/50d)LA without drug. At 4 months dexamethasone induced both chronic inflammatory changes and foreign body reaction, whereas the reactions in the indomethacin and drug-free plain SR-PLDLA groups were insignificant. The new biodegradable drug-eluting stent materials are highly biocompatible. Drug-eluting biodegradable stents may offer a promising new treatment modality for vascular and urethral diseases. However, further studies are needed to demonstrate their feasibility and efficacy. |
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