Development of drug-coated balloon for the treatment of multiple peripheral artery segments

Anderson, Jordan A.; Lamichhane, Sujan; Fuglsby, Kirby; Remund, Tyler; Pohlson, Kathryn; Evans, Rick L.; Engebretson, Daniel; Kelly, Patrick

doi:10.1016/j.jvs.2019.04.494

Cited by 3 publications

(17 citation statements)

References 21 publications

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“…The characteristic PAT peaks were observed only in the PAT control and PAT–PEO physical powder mixture and not in the any of the balloon samples (Anderson et al, ). This suggests that the PAT is molecularly dispersed in the PEO matrix of the balloon coatings (Figure 8b) as we have previously seen (Anderson et al, ; Anderson et al, ; Anderson et al, ).…”

Section: Resultssupporting

confidence: 82%

“…The PAT powder demonstrated an endothermic peak at 221°C, indicating a crystalline nature for the PAT powder. Importantly, this peak does not exist for Balloons 4, 11, 16, or 22, indicating that PAT is in the amorphous form in the balloon coatings (Figure 8a) as previously reported (Anderson et al, ; Anderson et al, ).…”

Section: Resultssupporting

confidence: 79%

“…PEO was sterilized prior to use by ethylene oxide. The coating formulation was prepared as previously described (Anderson et al, ). The PAT–PEO solution was prepared by dissolving PEO (10%, wt/vol) in deionized water and allowed to stir at 400 rpm for 6 hr at room temperature.…”

Section: Methodsmentioning

confidence: 99%

“…To assess coating uniformity prior to each inflation (Anderson et al, ), the balloon was imaged using a dissecting microscope following the 30 s initial transit period and prior to inflation in the first artery. Two balloons were used for each balloon type to obtain a total of six images, with a minimum of three images obtained from each balloon.…”

Section: Methodsmentioning

confidence: 99%

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Development of an automated micropipette coating method for drug‐coated balloons

et al. 2020

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Drug-coated balloons (DCBs) are a recent technology developed to treat peripheral artery disease (PAD). Along with a suitable formulation of antiproliferative drug and excipient, coating method is an important aspect of a DCB as these factors affect coating characteristics and drug delivery to the treatment site. The multiple release tailored medical devices DCB (MR-TMD-DCB), designed to achieve multiple inflations to treat complex PAD, contains paclitaxel (PAT) as the antiproliferative drug and polyethylene oxide (PEO) as the excipient. In our previous studies, the MR-TMD-DCB was coated using a manual dip coating method. In this study, an automated micropipette coating method was developed using a modified spray coating instrument to coat the MR-TMD-DCB. First, the coating formulation and strategy was optimized. A drug formulation of 16 wt% PAT and 4% wt/vol PEO, a polymer formulation of 2.5% wt/vol PEO, and a total of two drug layers produced a mostly uniform and thin coating with no defects and acceptable drug load. The balloon also had optimal drug uptake in arterial tissue in an in vitro flow model. Next, the reproducibility of the coating strategy was improved by optimizing the instrument parameters. The optimized instrument parameters (translational speed = 0.150 in/s, revolution rate = 100 rpm, flow rate = 0.6 ml/min) resulted in improved reproducibility of the drug load and similar coating properties as the DCB. This study demonstrated the ability to automate the micropipette process to obtain a balloon with optimal coating properties and drug tissue uptake.

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Section: Resultssupporting

confidence: 82%

Section: Resultssupporting

confidence: 79%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

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Development of an automated micropipette coating method for drug‐coated balloons

et al. 2020

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“…Irrespective of the mode by which DCB deployment is approximated in bench‐top studies, subsequent analyses that quantify constituent transfer to and retention within the arterial tissue will provide key response variables to guide iterative device design. In terms of coating composition and transfer, scanning electron microscopy (SEM) images of the coating surface before and after controlled interaction with arterial tissue can be processed to quantify coating dissociation from the balloon, 20 , 55 , 58 , 59 while analogous wet SEM imaging of the tissue surface can elucidate coating retention within the arterial wall. To assess drug transfer efficiency, acutely delivered drug levels can be measured via high‐performance liquid chromatography (HPLC) of arterial tissue samples following simulated DCB deployment and compared to the initial drug content of the coating.…”

Section: Biophysics‐based Design Considerations and Strategiesmentioning

confidence: 99%

Understudied factors in drug‐coated balloon design and evaluation: A biophysical perspective

Shazly

Torres

Secemsky

et al. 2022

Bioengineering & Transla Med

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Drug‐coated balloon (DCB) percutaneous interventional therapy allows for durable reopening of the narrowed lumen via physical tissue expansion and local anti‐restenosis drug delivery, providing an alternative to traditional uncoated balloons or a permanent indwelling implant such as a conventional metallic drug‐eluting stent. While DCB‐based treatment of peripheral arterial disease (PAD) has been incorporated into clinical guidelines, DCB use has been recently curtailed due to reports that showed evidence of increased mortality risk in patients treated with paclitaxel (PTX)‐coated balloons. Given the United States Food and Drug Administration's 2019 consequent warning regarding PTX‐eluting DCBs and the subsequent marked reduction in clinical DCB use, there is now a critical need to better understand the compositional and mechanical factors underlying DCB efficacy and safety. Most work to date on DCB refinement has focused on designing both the enabling balloon catheter and alternate coatings composed of various drugs and excipients, followed by device evaluation in preclinical and clinical studies. We contend that improvement in DCB performance will require a better understanding of the biophysical factors operative during and following balloon deployment, and moreover that the elaboration and demonstrated control of these factors are needed to address current concerns with DCB use. This article provides a perspective on the biophysical interactions that govern DCB performance and offers new design strategies for the development of next‐generation DCB devices.

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Multiple-release paclitaxel-coated angioplasty balloon is a step forward, but focus needs to be on paclitaxel safety

Farber

2020

Journal of Vascular Surgery

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Development of drug-coated balloon for the treatment of multiple peripheral artery segments

Cited by 3 publications

References 21 publications

Development of an automated micropipette coating method for drug‐coated balloons

Development of an automated micropipette coating method for drug‐coated balloons

Understudied factors in drug‐coated balloon design and evaluation: A biophysical perspective

Multiple-release paclitaxel-coated angioplasty balloon is a step forward, but focus needs to be on paclitaxel safety

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