Medical Device News Magazine

Friday, March 24, 2023

Irrimax Receives FDA Clearance for Irrisept

Irrimax Corporation, manufacturer of Irrisept, announces new clearance from the U.S. Food and Drug Administration (FDA), making Irrisept the only self-contained irrigation system for antimicrobial wound lavage in the U.S. market.

Today, more than 2,000 U.S. hospitals are using the Irrisept product totaling more than 2 million lifetime uses.

As a result of the new clearance, Irrimax announces a new product name “Irrisept Antimicrobial Wound Lavage”.  The indications for use now include the mechanical cleansing and removal of microorganisms.

“This new clearance from the FDA further solidifies Irrisept as the market leader in wound irrigation,” said Mark Alvarez, CEO of Irrimax. “Looking ahead, our goal for Irrisept remains to become the Standard of Care in the U.S. and across the globe. This clearance is a significant step toward that goal.”

Irrisept Antimicrobial Wound Lavage is offered as a single-use, manual, self-contained irrigation device comprised of 0.05% Chlorhexidine Gluconate (CHG) in 99.95% Sterile Water for Irrigation, USP. CHG acts as a highly effective preservative 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.1

The performance profile of Irrisept is demonstrated by its mechanical action that aids in the cleansing and removal of debris, dirt and foreign materials, including microorganisms, from wounds. 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.2

The safety profile of Irrisept has been well established through extensive biocompatibility testing.3 In a simulated wound model, irrigation with Irrisept was shown to be equivalent in wound healing properties to irrigation with normal saline.4 Furthermore, the Irrisept solution is aseptically processed and formulated with a precise concentration of 0.05% CHG.

Irrisept offers ease of use with a packaging configuration that is sterile, easy to open and ready to use. There is no mixing, dispensing or attachment to an additional irrigation system needed.

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