Preclinical Safety
Abstracts
Posters
Peer Review Publications


Preclinical Safety
SprayGel has been subjected to all the tests outlined in the U.S. Food and Drug Administration General Program Memorandum #G95-1 entitled, Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing."



Preclinical Efficacy
SprayGel has been shown to prevent post-surgical abdominopelvic and cardiac adhesion formation in four different preclinical models. More information on preclinical efficacy can be found in the following publications:

  • Evaluation in the rat cecum and rabbit uterine horn adhesion models
  • Evaluation in a porcine efficacy model

Clinical Efficacy
SprayGel has been evaluated in one European and one US clinical trial to date.

 

SprayGel is not approved for sale in the United States.
SprayGel is currently under clinical investigations in the U.S.

 






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