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The objective of the study is to investigate the safety, feasibility, and degradation profile of a novel Mg alloy-based bioresorbable coronary scaffold (JFK-PRODUCT BRS) with thin struts (110 μm). Fourteen healthy pigs received 17 JFK-PRODUCT BRSs in the coronary arteries and were sacrificed at 1, 6, 12, 18, and 26 months after implantation. Angiography, optical coherence tomography, microfocus X-ray computed tomography (μCT), scanning electron microscopy with energy-dispersive X-ray spectrometry (SEM–EDX), and histopathological evaluation were performed. The JFK-PRODUCT had a median percent late recoil of 11.28% at 1 month. The μCT observation confirmed that scaffold discontinuity reached 64.8% at 12 months with increased scaffold inner area thereafter, suggesting artery positive remodeling. The inflammation was mild, peaked at 18 months, and decreased thereafter. The SEM–EDX analysis demonstrated gradual degradation of the scaffold with formation of inorganic deposits, presumed to be calcium phosphates. It also revealed the disappearance of calcium phosphates at 26 months, achieving almost complete replacement of the scaffold by biocomponents.

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• Creative Commons BY Attribution 4.0 International
  

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Keyword: Percutaneous coronary intervention, Bioabsorbable magnesium scaffolds, Preclinical study, Elemental mapping, Controlled degradation profile

Date published: 2024-07-22

Publisher: Springer Science and Business Media LLC

Journal:

• Cardiovascular Intervention and Therapeutics (ISSN: 18684300) vol. 39 issue. 4 p. 428-437

Funding:

• AMED 18pc0101027h0001 (CiCLE)

Manuscript type: Publisher's version (Version of record)

MDR DOI:

First published URL: https://doi.org/10.1007/s12928-024-01023-3

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Updated at: 2024-10-18 16:30:14 +0900

Published on MDR: 2024-10-18 16:30:15 +0900