Document Detail

From bench to bedside: initial experience with the Primus drug-coated balloon catheter.
MedLine Citation:
PMID:  23018430     Owner:  NLM     Status:  In-Data-Review    
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.
C Briguori; R Virmani; F Kolodgie; R A Byrne; K Steigerwald; M Orlowski; M Joner
Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Minerva cardioangiologica     Volume:  60     ISSN:  0026-4725     ISO Abbreviation:  Minerva Cardioangiol     Publication Date:  2012 Oct 
Date Detail:
Created Date:  2012-09-28     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0400725     Medline TA:  Minerva Cardioangiol     Country:  Italy    
Other Details:
Languages:  eng     Pagination:  507-15     Citation Subset:  IM    
Laboratory of Interventional Cardiology and Department of Cardiology, Clinica Mediterranea, Naples, Italy -
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