Abstract
Abstract For product approval of coated cardiovascular devices, the assessment of particle release is essential. Particularly challenging are delivery systems equipped with hydrophilic coatings releasing highly transparent particles. The aim of this study was to compare two different methods of particle counting, namely the light obscuration method and the dynamic image analysis (DIA), with respect to optical transparent particles. The particles were collected during the simulated use of cardiovascular catheters and analysed in suspension with a dynamic imaging device (FlowCam, Fluid Imaging Technologies). Particles were detected by a greyscale threshold and imaged to analyse their shape and transparency. The statistical influence of the threshold on particle counts and size distribution was determined and compared to light obscuration particle counting (Model 9703 with sensor HRLD 400CE, HIAC ROYCO). The light obscuration method provided lower particle counts in suspensions containing a high amount of transparent particles. The lower the detection threshold, the higher the particle counts were. In conclusion, it is important to adapt the threshold value for samples that are expected to contain a high amount of transparent particles. DIA may be suggested as a valuable additional method for particulate analysis.
Highlights
IntroductionCardiovascular implants such as drug coated balloons (DCB) or drug eluting stents (DES) are used to treat coronary artery disease
Cardiovascular implants such as drug coated balloons (DCB) or drug eluting stents (DES) are used to treat coronary artery disease. The approval of those implants includes the analysis of particulate matter, because particles released into the blood stream can increase the risk of emboli [1]
The determination of the threshold value has a high influence on the particle counting and sizing
Summary
Cardiovascular implants such as drug coated balloons (DCB) or drug eluting stents (DES) are used to treat coronary artery disease. The approval of those implants includes the analysis of particulate matter, because particles released into the blood stream can increase the risk of emboli [1]. In this study the focus is set on particles emitted from devices that have a hydrophilic coating. These coatings are used to avoid friction and damages of the vessel wall during the implantation process [1] The particles were collected during the simulated use of cardiovascular catheters and analysed in suspension. The aim of the study was to test the sensitivity of both methods for the detection and the size determination of transparent particles
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