Please use this identifier to cite or link to this item: doi:10.22028/D291-33210
Title: Novel, vessel anatomy adjusting drug-coated balloon-Preclinical evaluation in peripheral porcine arteries
Author(s): Bienek, Stephanie
Kusmierczuk, Maciej
Mittag, Antje
Bettink, Stephanie
Scheller, Bruno
Language: English
Title: Catheterization and Cardiovascular Interventions
Volume: 95
Issue: 2
Pages: 319–328
Publisher/Platform: Wiley
Year of Publication: 2019
Free key words: drug transfer
inhibition of neointimal proliferation
vessel anatomy adjusting drug-coated balloon
DDC notations: 610 Medicine and health
Publikation type: Journal Article
Abstract: The diameter of balloons or stents is selected according to the estimated reference vessel diameter and do not adapt to the vessel anatomy. The aim of the present preclinical studies was to investigate a novel, vessel anatomy adjusting hypercompliant drug-coated balloon catheter (HCDCB).Methods Hypercompliant balloon membranes were coated in a constricted state with high drug density. Drug adherence was investigated in vitro, transfer to the porcine peripheral arteries and longitudinal distribution in vivo. In young domestic swine, neointimal proliferation was induced by vessel overstretch and continuous irritation by permanent stents. Uncoated hypercompliant balloons (HCB), and standard uncoated balloons and drug‐coated balloons (DCB) served as controls. Efficacy was assessed by angiography, optical coherence tomography (OCT), and histomorphometry. Results HCDCB lost 18.0 ± 3.9% of dose during in vitro simulated delivery to the lesion. Drug transfer to the vessel wall was 13.9 ± 6.4% and drug concentration was 1,044 ± 529 ng/mg tissue. Four weeks after treatment, the histomorphometric neointimal area was smaller with HCDCB versus uncoated HCB (2.39 ± 0.55 mm2 vs. 3.26 ± 0.72 mm2, p = .038) and area stenosis (OCT) was less (11.6 ± 6.9% vs. 24.7 ± 9.7%, p = .022). No premature death occurred and no in‐life clinical symptoms or treatment‐associated thrombi were observed. Conclusions HCDCB were found to inhibit excessive neointimal proliferation. Balloon adaption to different vessel diameters and shapes may provide drug‐delivery in irregular lumen and facilitate balloon selection.
DOI of the first publication: 10.1002/ccd.28592
Link to this record: urn:nbn:de:bsz:291--ds-332106
ISSN: 1522-726X
Date of registration: 4-Feb-2021
Faculty: M - Medizinische Fakultät
Department: M - Innere Medizin
Professorship: M - Keiner Professur zugeordnet
Collections:SciDok - Der Wissenschaftsserver der Universität des Saarlandes

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