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Intrathrombus polymer coating deposition: a pilot study of 91 patients undergoing endovascular therapy for acute large vessel stroke. Part I: Histologic frequency
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  • Published on:
    Proprietary nature of intravascular medical device coatings limits safety testing
    • Rashi I Mehta, Neuroradiologist West Virginia University Department of Neuroradiology
    • Other Contributors:
      • Ansaar T Rai, Interventional Neuroradiologist
      • James W Simpkins, Director, Center for Basic and Translational Stroke Research
      • Rupal I Mehta, Neuropathologist

    Proprietary nature of intravascular medical device coatings limits safety testing

    Dear Dr. Albuquerque:

    We are glad that our work has generated interest and discussion in the field [1]. Four years have elapsed since a need for updated device coating testing was officially announced [2], however complexities on the matter and persistent knowledge gaps limit safety studies of devices currently on the market for clinical intravascular use [3,4]. Standardized in vitro particulate generation testing is needed. However, available literature shows that preclinical device testing is not fully predictive of clinical response. Therefore, in vitro and animal studies cannot replace investigation in humans. Currently, lack of consensus on the following prevent meaningful testing in humans: I) optimal clinical testing methods; ii) definitions of permissible risk; iii) adverse cellular, organ, and temporal-specific effects of distinct coating biomaterials; and iv) effects of pre-existing comorbid conditions. Nevertheless, in vitro testing that does not incorporate clinical data has limited utility for safety guidance. Likewise, in vivo studies that do not incorporate biomaterial factors are incomplete. Thus, the proprietary nature of intravascular device coatings remains a significant limitation to clinical device testing and safety assurances. Growing data [2-6] suggest that it may be time for this to be addressed.

    1. Chopra AM, Hu YC, Cruz JP. The Device Specific...

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    Conflict of Interest:
    ATR serves as a consultant for Stryker Corporation.
  • Published on:
    The Device Specific Nature of Polymer Coating Emboli: An Optimal Approach For Future Investigations Related to Polymer Embolism
    • Amitabh M Chopra, Chemical Engineer / Medical Researcher Self Employed
    • Other Contributors:
      • Yin C Hu, Department of Neurosurgery
      • Juan P Cruz, Department of Radiology

    An increasing number of reports highlight polymer coating embolism as an iatrogenic complication of intravascular medical devices [1-3]. Autopsies, histologic evaluations of thrombectomy specimens, samples of captured debris, resected or biopsied tissues, are available methods used to study polymer emboli post investigative catherizations or interventional procedures. Reported data highlight the prevalence of this phenomenon and/or its clinicopathologic impacts, however, fall short of identifying higher-risk polymer emboli interventional devices. Consequently, an optimal approach for future investigations related to polymer coating embolism is required.

    Mehta et. al investigate the histologic frequency of polymer emboli among patients who underwent endovascular thrombectomy for treatment of acute ischemic stroke due to large vessel occlusion by retrospectively evaluating thrombectomy specimens [2]. In this study, the reported frequency of polymer emboli includes the use of various devices and techniques among selected cases. However, literature highlights polymer coating embolism is device specific and dependent on coating integrity measured by particulates released [4]. Thus, the use of alternate devices with higher or lower particulate release for a given procedure may result in a large variation in incidence rates from reported results. Also, as mentioned by the authors, subsequent statistical correlations unless appropriately powered provide limited informatio...

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    Conflict of Interest:
    None declared.