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FDA expands indications for HemCon's bandages

This article was originally published in Clinica

Executive Summary

The US FDA has expanded the clearance of HemCon's dressings and bandages to include their use as an antibacterial barrier against MRSA. The 510(k) clearance covers the Portland, Oregon firm's HemCon Bandages, ChitoFlex dressings and KytoStat Bandages, which are made from chitosan, a substance found in shrimp shells. The approval means that they may now be used for a wide range of other Gram-positive and –negative organisms, including Enterococcus faecalis and Acinetobacter baumanii, as well as for controlling bleeding in patients following haemodialysis. The bandages were first approved in the US in 2005 as an antibacterial barrier against Staphylococcus aureus and Klebsiella pneumonia, and are also CE marked in Europe for the original indications, along with emergency and haemodialysis use.

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