1. Pre-Clinical Investigation of Keratose as an Excipient of Drug Coated Balloons.
- Author
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Goel E, Erwin M, Cawthon CV, Schaff C, Fedor N, Rayl T, Wilson O, Christians U, Register TC, Geary RL, Saul J, and Yazdani SK
- Subjects
- Angioplasty, Balloon, Animals, Cardiovascular Agents administration & dosage, Drug Evaluation, Preclinical, Immunohistochemistry, Paclitaxel administration & dosage, Peripheral Arterial Disease drug therapy, Peripheral Arterial Disease etiology, Peripheral Arterial Disease metabolism, Peripheral Arterial Disease pathology, Antineoplastic Agents administration & dosage, Coated Materials, Biocompatible, Drug Carriers chemistry, Drug Delivery Systems, Keratosis
- Abstract
Background: Drug-coated balloons (DCBs), which deliver anti-proliferative drugs with the aid of excipients, have emerged as a new endovascular therapy for the treatment of peripheral arterial disease. In this study, we evaluated the use of keratose (KOS) as a novel DCB-coating excipient to deliver and retain paclitaxel., Methods: A custom coating method was developed to deposit KOS and paclitaxel on uncoated angioplasty balloons. The retention of the KOS-paclitaxel coating, in comparison to a commercially available DCB, was evaluated using a novel vascular-motion simulating ex vivo flow model at 1 h and 3 days. Additionally, the locoregional biological response of the KOS-paclitaxel coating was evaluated in a rabbit ilio-femoral injury model at 14 days., Results: The KOS coating exhibited greater retention of the paclitaxel at 3 days under pulsatile conditions with vascular motion as compared to the commercially available DCB (14.89 ± 4.12 ng/mg vs. 0.60 ± 0.26 ng/mg, p = 0.018). Histological analysis of the KOS-paclitaxel-treated arteries demonstrated a significant reduction in neointimal thickness as compared to the uncoated balloons, KOS-only balloon and paclitaxel-only balloon., Conclusions: The ability to enhance drug delivery and retention in targeted arterial segments can ultimately improve clinical peripheral endovascular outcomes.
- Published
- 2020
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