IrriSept Wound Debridement and Cleansing System With CHG is Introduced

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Hospitals now have an alternative to saline irrigation with the introduction of IrriSept®, the first and only FDA-cleared wound debridement and cleansing system containing chlorhexidine gluconate (CHG). The 0.05 percent CHG concentration in IrriSept has been shown effective in laboratory testing against a variety of bacteria and fungi, including staph and methicillin-resistant Staphylococcus aureus (MRSA).(1,2) The solution has passed Food and Drug Administration (FDA)-required tests for cytotoxicity, skin irritation and immune (allergic) response.(3)

"Our goal is to improve patient outcomes by treating and cleaning wounds to help resolve and/or prevent infections, and to increase the safety of medical professionals. IrriSept has the potential to become the new standard of care for wound debridement and cleansing."

.Instead of cleansing a wound with just normal saline, healthcare professionals can now apply IrriSept with CHG directly to surgical or deep traumatic wounds, burns, abrasions, lacerations, SSTIs including abscesses, delayed closures, dehiscence, pilonidal cysts or infected wounds. IrriSept is designed for use in operating rooms, wound care centers, Emergency Departments, burn units and other healthcare settings.

Developed by IrriMax® Corporation, IrriSept’s delivery system is as simple as:

- Step 1: Debride and cleanse. Through bottle compression, the patented IrriSept system delivers 450mL of solution in less than 30 seconds to effectively loosen and remove wound debris and bacteria without harming underlying tissues.

- Step 2: Rinse one minute later with IrriRinse®.

IrriSept is available for use in surgical and non-surgical environments. The surgical product -- labeled IrriSept O.R. -- includes a choice of three irrigation applicators: the original SplatterGuard® and the LT SplatterGuard®, designed specifically for abscess cleansing, that reduce healthcare workers’ exposure to biohazard aerosolized contamination, as well as the IrriProbe™ for deeper wound cleansing. The non-surgical product -- labeled IrriSept -- includes the same applicators with the exception of the O.R.-specific IrriProbe.

"Once healthcare practitioners understand the science behind the IrriSept system and its key ingredient CHG, they recognize its tremendous value," says IrriMax CEO Gareth Clarke. "Our goal is to improve patient outcomes by treating and cleaning wounds to help resolve and/or prevent infections, and to increase the safety of medical professionals. IrriSept has the potential to become the new standard of care for wound debridement and cleansing."

CHG is not new to the medical arena. It is used as the active ingredient in surgical hand scrubs and also is applied topically as a surgical and IV catheter skin prep disinfectant. In addition, CHG is used in oral mouth rinses for treatment of gingivitis.

Clarke, who was the driving force behind the global growth of Biogel® surgical gloves, was easily lured out of his recent retirement to oversee commercial development of IrriSept because he believes so strongly in the product. "There have been no significant advances in wound cleansing and irrigation since the introduction of saline," explains Clarke. "However, our case studies demonstrate significant patient improvements when IrriSept is used. We believe IrriSept has the potential to improve patient outcomes, reduce hospital lengths of stay and safeguard healthcare workers. Patients, providers and insurers can all benefit from this product."

IrriSept and its delivery system were conceived by company founder Dr. Paul Rucinski, a former emergency medicine physician. He recognized the crucial need for a rapid and effective irrigation product. With IrriSept’s unique capabilities and easy-to-use application, the product answers the demand for today’s healthcare institutions to address increasing infection-related challenges.

IrriSept can be purchased directly from IrriMax or from Medline Industries (www.medline.com).

References:

1. Laboratory Testing Records per USP <51>, Antimicrobial Effectiveness Testing, on file at IrriMax Corporation.

2. Laboratory Testing Records, "Chlorhexidine Gluconate (CHG) Bacterial Study Report," on file at IrriMax Corporation.

3. Biocompatibility compliance tests completed per FDA’s Blue Book Memorandum G95-1 and ISO 10993-1, Biological Evaluation of Medical Devices, on file at IrriMax Corporation.

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