| From bench to bedside: initial experience with the Primus drug-coated balloon catheter. | |
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MedLine Citation:
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PMID: 23018430 Owner: NLM Status: In-Data-Review |
Abstract/OtherAbstract:
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AIM: Drug-coated balloon (DCB) technology has emerged as a promising therapy particularly in the treatment of coronary in-stent restenosis. Although a variety of devices are available for clinical use, clinical outcomes have been variable and scope for significant improvement exists. METHODS: In a preclinical study, a total of 10 juvenile healthy farm pigs underwent catheter-based DCB deployment in coronary arteries with angiographic and pathological follow-up at 7 or 28 days. Animals were randomly allocated to the PRIMUS or Dior® DCB (N.=10 per group) and evaluated by histopathology and morphometric analysis. In a first-in-man clinical study a total of 19 consecutive patients presenting with restenosis within drug-eluting stents were treated with the PRIMUS DCB. Clinical follow-up was performed out to 6 months. RESULTS: Neointimal thickness was similar between the PRIMUS and Dior® DCB groups, while fibrin deposition and inflammation were more sustained in the PRIMUS group at 28 days. In 19 consecutive patients presenting with in-stent restenosis of drug-eluting stents, treatment with the PRIMUS DCB catheter resulted in high procedural efficacy. There were no adverse clinical events observed out to 6 months. CONCLUSION: The PRIMUS DCB demonstrates high preclinical safety and excellent acute performance and safety. Further studies are needed to delineate the relative merits of this novel DCB compared to other devices. |
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Authors:
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C Briguori; R Virmani; F Kolodgie; R A Byrne; K Steigerwald; M Orlowski; M Joner |
Publication Detail:
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Type: Journal Article |
Journal Detail:
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Title: Minerva cardioangiologica Volume: 60 ISSN: 0026-4725 ISO Abbreviation: Minerva Cardioangiol Publication Date: 2012 Oct |
Date Detail:
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Created Date: 2012-09-28 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 0400725 Medline TA: Minerva Cardioangiol Country: Italy |
Other Details:
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Languages: eng Pagination: 507-15 Citation Subset: IM |
Affiliation:
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Laboratory of Interventional Cardiology and Department of Cardiology, Clinica Mediterranea, Naples, Italy - michaeljoner@me.com. |
Export Citation:
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Descriptor/Qualifier:
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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