Instrumentation

Schmidt, W. J.; Lanzer, Peter

doi:10.1007/978-3-642-27676-7_27

Cited by 12 publications

(13 citation statements)

References 24 publications

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“…As aforementioned these size limits are adopted from assessment of surface and coating damage of stent delivery catheters [24]. The results for the particle counting test are given in Table 1 and given in number of particles per mm² balloon surface (#/mm²).…”

Section: Resultsmentioning

confidence: 99%

Correlating Coating Characteristics with the Performance of Drug-Coated Balloons – A Comparative In Vitro Investigation of Own Established Hydrogel- and Ionic Liquid-Based Coating Matrices

et al. 2015

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Drug-coated balloons (DCB), which have emerged as a therapeutic alternative to drug-eluting stents in percutaneous cardiovascular intervention, are well described with regard to clinical efficacy and safety within a number of clinical studies. In vitro studies elucidating the correlation between coating additive and DCB performance are however rare but considered important for the understanding of DCB requirements and the improvement of established DCB. In this regard, we examined three different DCB-systems, which were developed in former studies based on the ionic liquid cetylpyridinium salicylate, the body-own hydrogel hyaluronic acid and the pharmaceutically well-established hydrogel polyvinylpyrrolidone, considering coating morphology, coating thickness, drug-loss, drug-transfer to the vessel wall, residual drug-concentration on the balloon surface and entire drug-load during simulated use in an in vitro vessel model. Moreover, we investigated particle release of the different DCB during simulated use and determined the influence of the three coatings on the mechanical behavior of the balloon catheter. We could show that coating characteristics can be indeed correlated with the performance of DCB. For instance, paclitaxel incorporation in the matrix can reduce the drug wash-off and benefit a high drug transfer. Additionally, a thin coating with a smooth surface and high but delayed solubility can reduce drug wash-off and decrease particle burden. As a result, we suggest that it is very important to characterize DCB in terms of mentioned properties in vitro in addition to their clinical efficacy in order to better understand their function and provide more data for the clinicians to improve the tool of DCB in coronary angioplasty.

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Section: Resultsmentioning

confidence: 99%

Correlating Coating Characteristics with the Performance of Drug-Coated Balloons – A Comparative In Vitro Investigation of Own Established Hydrogel- and Ionic Liquid-Based Coating Matrices

et al. 2015

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“…The process of coronary balloon angioplasty was simulated using an in vitro model, recently described in literature [24], consisting of a guiding catheter (Cordis Brite Tip; 5F; 100 cm; 1.4 mm ID) with a guide wire (Biotronik Galeo M014) and a tortuous path revetted with a polytetrafluoroethylene (PTFE) tube. The anatomic model was equivalent to the model described in American Society for Testing and Materials (ASTM) F2394-07, X.2.4 (PM-40/2010) surrounded by 37 ± 2°C heated water.…”

Section: Simulated Usementioning

confidence: 99%

Development and in Vitro Characterization of Photochemically Crosslinked Polyvinylpyrrolidone Coatings for Drug-Coated Balloons

Petersen¹,

Minrath²,

Kaule³

et al. 2013

Coatings

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Polyvinylpyrrolidone (PVP) is a conventionally applied hydrophilic lubricious coating on catheter-based cardiovascular devices, used in order to ease movement through the vasculature. Its use as drug reservoir and transfer agent on drug-coated balloons (DCB) is therefore extremely promising with regard to the simplification of its approval as a medical device. Here, we developed a PVP-based coating for DCB, containing paclitaxel (PTX) as a model drug, and studied the impact of crosslinking via UV radiation on drug stability, wash off, and transfer during simulated use in an in vitro vessel model. We showed that crosslinking was essential for coating stability and needed to be performed prior to PTX incorporation due to decreased drug bioavailability as a result of photodecomposition and/or involvement in vinylic polymerization with PVP under UV radiation. Moreover, the crosslinking time needed to be carefully controlled. While short radiation times did not provide enough coating stability, associated with high wash off rates during DCB insertion, long radiation times lowered drug transfer efficiency upon balloon expansion. A ten minutes radiation of PVP, however, combined a minimized drug wash off rate of 34% with an OPEN ACCESSCoatings 2013, 3 254 efficient drug transfer of 49%, underlining the high potential of photochemically crosslinked PVP as a coating matrix for DCB.

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“…With respect to the mechanical performance, PRO‐Kinetic Energy had similar trackability but better crossability and pushability than Multi‐Link Vision (Figure ). Crossability is the ability of a stent system to pass a narrowing of the lumen so that stent can be positioned exactly across the target lesion . Pushability is the ability to overcome obstacles while advancing a stent into coronary vessels, that is, the ability to efficiently transfer the proximally applied push force to the catheter tip …”

Section: Resultsmentioning

confidence: 99%

“…The pushability is the ability to advance a SDS in coronary vessels conveniently, represented by the efficacy of transfer of the proximally applied push force to the catheter tip. The higher the ratio between distally measured and proximally applied forces, the higher the pushability and greater ability to overcome obstacles …”

Section: Methodsmentioning

confidence: 99%

Still room for improvement: Preclinical and bench testing of a thin‐strut cobalt–chromium bare‐metal stent with passive coating

Wittchow

Hartwig

2016

J Biomed Mater Res

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There is a renewed interest in bare-metal stent (BMS) design as degradable polymer coatings are increasingly used as drug-delivery vehicles in drug-eluting stents (DESs), leaving it to the BMS platform to determine the long-term outcome of DES treatment. In this study comprising preclinical and bench tests, we compare two modern thin-strut BMSs of different design. Angiography, morphometry, and histopathology data were acquired in a porcine coronary artery model in a 28-day single-stent study (13 hybrid farm pigs) and in a 90-day overlapping-stent study (8 Yucatan mini-pigs). Standardized bench tests including ion release test were performed to compare mechanical performance of the two stent systems. We found that the optimized stent group induced significantly less neointimal formation and less inflammation than Multi-Link Vision in both (single stent and overlapping stent) porcine studies. The higher efficacy was also associated with a markedly reduced release of cobalt, nickel, chromium, and tungsten ions in physiological solution and better performance in mechanical delivery tests. In conclusion, a further increase in efficacy and better safety profile than the well-known Multi-Link Vision BMS can be achieved by careful optimization of the BMS backbone. © 2016 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 105B: 1612-1621, 2017.

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Instrumentation

Cited by 12 publications

References 24 publications

Correlating Coating Characteristics with the Performance of Drug-Coated Balloons – A Comparative In Vitro Investigation of Own Established Hydrogel- and Ionic Liquid-Based Coating Matrices

Correlating Coating Characteristics with the Performance of Drug-Coated Balloons – A Comparative In Vitro Investigation of Own Established Hydrogel- and Ionic Liquid-Based Coating Matrices

Development and in Vitro Characterization of Photochemically Crosslinked Polyvinylpyrrolidone Coatings for Drug-Coated Balloons

Still room for improvement: Preclinical and bench testing of a thin‐strut cobalt–chromium bare‐metal stent with passive coating

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