Subject(s)
Angioplasty, Balloon, Coronary/instrumentation , Cardiovascular Agents/administration & dosage , Coronary Artery Disease/therapy , Drug-Eluting Stents , Metals , Stents , Angioplasty, Balloon, Coronary/adverse effects , Angioplasty, Balloon, Coronary/economics , Cardiovascular Agents/economics , Cardiovascular Diseases/etiology , Clinical Trials as Topic , Coronary Artery Disease/economics , Cost-Benefit Analysis , Drug-Eluting Stents/economics , Health Care Costs , Humans , Platelet Aggregation Inhibitors/therapeutic use , Prosthesis Design , Registries , Stents/economics , Treatment OutcomeABSTRACT
PURPOSE: 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.
Subject(s)
Alloys , Foreign-Body Reaction , Models, Animal , Stents , Animals , Immunohistochemistry , Microscopy, Electron, Scanning , Swine , Swine, MiniatureABSTRACT
Study was conducted on 20 subjects with non bacterial chronic rhinopharyngitis. Forty-one virus strains, mainly adenoviruses, type 3 parainfluenza virus, influenza and type 1 herpes viruses, as well as enteroviruses were isolated from samples collected at regular intervals. After the NIVGRIP (R) vaccination, the number of subjects with viruses present in the pharynx decreased by 75% (from 20 to 5 positive patients) and that of isolates from 41 to 6 (80% positive samples before vaccination against 10% after immunization).
