FDA Clearance (US only)

FDA Clearance (US only)
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  • Federal Drug Administration (FDA) cleared, in a report dated on May 27, 2005, MARS therapy for the treatment of drug overdose and poisoning. The handiest requirement is that the drug or poison should be liable to be dialyzed and eliminated with the aid of activated charcoal or anionic alternate resins.
  • More recently, on December 17, 2012, MARS remedy has been cleared through the FDA for the remedy of hepatic encephalopathy because of a decompensation of a chronic liver ailment Clinical trials carried out with MARS remedy in HE patients having a decompensation of persistent liver sickness established a temporary effect from MARS remedies to noticeably decrease their hepatic encephalopathy rankings via at the least 2 grades in comparison to standard scientific therapy (SMT).
  • The MARS isn’t indicated as a bridge to liver transplant. Safety and efficacy has now not been demonstrated in managed, randomized scientific trials.
  • The effectiveness of the MARS device in sufferers which can be sedated couldn’t be installed in clinical research and therefore can’t be predicted in sedated sufferers

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