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A Journal on Heart and Vascular Diseases

Official Journal of the Italian Society of Angiology and Vascular Pathology
Indexed/Abstracted in: EMBASE, PubMed/MEDLINE, Science Citation Index Expanded (SciSearch), Scopus
Impact Factor 0,752

Frequency: Bi-Monthly

ISSN 0026-4725

Online ISSN 1827-1618


Minerva Cardioangiologica 2012 October;60(5):507-15


From bench to bedside: initial experience with the Primus drug-coated balloon catheter

Briguori C. 1, Virmani R. 2, Kolodgie F. 2, Byrne R. A. 3, Steigerwald K. 3, Orlowski M. 4, Joner M. 3

1 Laboratory of Interventional Cardiology and Department of Cardiology, Clinica Mediterranea, Naples, Italy;
2 CVPath Institute, Inc., Gaithersburg, MD, USA;
3 German Heart Center and Medical Clinic 1, Klinikum rechts der Isar, Technical University, Munich, Germany;
4 Cardionovum GmbH, Bonn, Germany

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.

language: English


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