title: Nitinol Carbofilm coated stents for peripheral applications: study in the porcine model.
abstract: OBJECTIVE
  Testing the safety and foreign body reaction (FBR) of a nitinol self-expandable carbon-coated stent system in the porcine animal model at different follow-up (FU) periods.
  
  
  METHODS
  Fifteen minipigs received 30 carbon-coated self-expandable nitinol stents in iliac arteries. Explants were carried out at 7 (3 animals), 30 (4 animals), 90 (4 animals) and 180 (4 animals) day FU, for evaluation of acute, sub-acute and chronic biological response to the implanted devices. Histological, immunohistochemical, histomorphometric and scanning electron microscopy (SEM) analyses were performed to assess inflammatory reaction, endothelialization process, neointimal growth and cellular composition.
  
  
  RESULTS
  Thirty stents were successfully implanted. No mural thrombi were observed at gross examination or by angiography. Histologically no significant inflammatory reaction was detected: the stents appeared covered by a thin monolayer of endothelial cells even at 7 day FU. The neointima presented homogeneous growth and moderate thickness after 30, 90 and 180 days explants (0.38+/- 0.36 mm, 0.33+/- 0.30 mm, 0.27+/- 0.25 mm respectively). Internal and external elastic laminae were intact in 95% of stented arteries. Histological data validations of vessel endothelialization was obtained with SEM for the seven day follow-up group.
  
  
  CONCLUSIONS
  This study showed good remarkable technical performances, minimal FBR and biocompatibility comparable with other available pre-clinical experimentations.
authors.affiliation: Department of Pathology & Immunology, CMU, University of Geneva, Switzerland. marco.prunotto@medecine.unige.ch
authors.forename: M
authors.initials: M
authors.lastname: Prunotto
authors.forename: C
authors.initials: C
authors.lastname: Isaia
authors.forename: M A
authors.initials: MA
authors.lastname: Gatti
authors.forename: E
authors.initials: E
authors.lastname: Monari
authors.forename: E
authors.initials: E
authors.lastname: Pasquino
authors.forename: M
authors.initials: M
authors.lastname: Galloni
mesh_terms: D000497:Alloys; D000818:Animals; D005549:Foreign-Body Reaction; D007150:Immunohistochemistry; D008855:Microscopy, Electron, Scanning; D023421:Models, Animal; D015607:Stents; D013552:Swine; D013556:Swine, Miniature
chemical_list: D000497:Alloys; C013616:nitinol