Research & Development
Irrimax Corporation wins FDA approval for Irrisept for antimicrobial wound lavage
18 June 2021 -

Infection company Irrimax Corporation revealed on Thursday the receipt of new clearance from the US Food and Drug Administration (FDA) for the only self-contained irrigation system Irrisept for antimicrobial wound lavage the mechanical cleansing and removal of microorganisms in the US.

Today, more than 2,000 US hospitals are using the Irrisept product totaling more than 2m lifetime uses. Following the new FDA clearance, the company has rebranded Irrisept to Irrisept Antimicrobial Wound Lavage.

The company said Irrisept Antimicrobial Wound Lavage is a single-use, manual, self-contained irrigation device comprised of 0.05% Chlorhexidine Gluconate (CHG) in 99.95% Sterile Water for Irrigation, USP to inhibit microbial growth in the solution. The device provides low pressure lavage that is easily controlled by the user and complies with recommendations per the American College of Surgeons.

According to the company, the CHG preservative in the Irrisept solution has demonstrated effectiveness against growth of a variety of both gram-positive and gram-negative bacteria, fungi and viruses. The safety profile of Irrisept has been well established through extensive biocompatibility testing. There is no mixing, dispensing or attachment to an additional irrigation system needed.

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