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    Polymer Embolism from Bioactive and Hydrogel Coil Embolization Technology: Considerations for Product Development | American Journal of Neuroradiology  
    



















    































    
  
  




    
    

  

      


    

      

  
  
  

    

  

    

  

                
    

      

  

    

  
      
  
  

    


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LetterLETTER

  
      

  
      
Polymer Embolism from Bioactive and Hydrogel Coil Embolization Technology: Considerations for Product Development
  
    	
A.M. Chopra, J.P. Cruz and Y.C. Hu

  
    	
American Journal of Neuroradiology July 2019,  40 (7) E34-E35; DOI: https://doi.org/10.3174/ajnr.A6083 

  
  
  



  


  
  



			

		

	
	
 	
	  
  

		
		

			

			  

  
      
  
  

    
  


  
  



  
      
  
  

    

  

    

  
      
  
  

    
REFERENCES
  1. 1.↵
    1. 

    2. Reinges  MH, 
    3. Krings  T, 
    4. Drexler  AY, et al
    . Bare, bio-active and hydrogel-coated coils for endovascular treatment of experimentally induced aneurysms: long-term histological and scanning electron microscopy results. Interv Neuroradiol 2010;16:139–50 doi:10.1177/159101991001600205 pmid:20642888
    CrossRefPubMed
  2. 2.↵
    1. 

    2. Killer  M, 
    3. Arthur  AS, 
    4. Barr  JD, et al
    . Histomorphology of thrombus organization, neointima formation, and foreign body response in retrieved human aneurysms treated with hydrocoil devices. J Biomed Mater Res B Appl Biomater 2010;94:486–92 doi:10.1002/jbm.b.31660 pmid:20574973
    CrossRefPubMed
  3. 3.↵
    1. 

    2. Chopra  AM, 
    3. Mehta  M, 
    4. Bismuth  J, et al
    . Polymer coating embolism from intravascular medical devices: a clinical literature review. Cardiovasc Pathol 2017;30:45–54 doi:10.1016/j.carpath.2017.06.004 pmid:28759819
    CrossRefPubMed
  4. 4.↵
    U.S. Food and Drug Administration Safety Communications. Lubricious Coating Separation from Intravascular Medical Devices: FDA Safety Communication. 
November 
23, 2015. http://wayback.archive-it.org/7993/20170404182155/https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm473794.htm. Accessed January 13, 2019. 
  5. 5.↵
    U.S. Food and Drug Administration. Recognized Consensus Standards. Recognition number 3–99, AAMI TIR42:2010. Evaluation of Particulates Associated with Vascular Medical Devices. Updated September 17, 2018. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=38909. Accessed 13 January 13, 2019. 
  


  
  



  




  


  
  



  
      
  
  

    
  


  
  



  
      
  
  

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Polymer Embolism from Bioactive and Hydrogel Coil Embolization Technology: Considerations for Product Development
  
    	
A.M. Chopra, J.P. Cruz, Y.C. Hu

  
    	
American Journal of Neuroradiology Jul 2019, 40 (7) E34-E35; DOI: 10.3174/ajnr.A6083 

  
  
  



  


  
  



  
      
  
  

    

  
    
  
  
    
  
  
    
  


  


  
  



  
      
  
  

    
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