Australian Wound Irrigation Device Cleared by FDA
Surgical site infections are the second largest cause of hospital acquired infections in the U.S. and a major cause of surgical complications and increased mortality around the world, according to Australian-based Next Science Limited.
XPERIENCE No Rinse Antimicrobial Solution
On April 23, 2021, the FDA notified the company that its single step application wound irrigation solution, XPERIENCE No Rinse Antimicrobial Solution, has been 510(k) cleared in the U.S. for immediate distribution. The device was originally submitted to the FDA as MIS Solution but is now being marketed as XPERIENCE.
The company says the residual solution remains in the surgical site after closure and, "continues to help defend against pathogens for several hours, giving surgeons a simple and effective adjunct to help prevent surgical site and post-operative infections."
Indications and Mechanisms of Action
According to the FDA documents, the device is a clear, colorless solution indicated for use in cleansing and removal of debris, including microorganisms from wounds.
The action of fluid moving across the wound is the mechanism of action that aids in the removal of debris. The device is provided in a soft polypropylene 500mL container with a spikeable port and is composed of water, citric acid, sodium citrate and sodium lauryl sulfate.
The mechanical action can be provided by either a manual syringe or powered irrigation device.
The device was evaluated in a Human Repeat Patch Test to evaluate the irritation endpoint in humans and was determined to be non-irritant. There were no adverse events or complications, according to the FDA documents.
The company says the single step application where the residual solution remains in the surgical site after closure and continues to help defend against pathogens for several hours, gives surgeons "a simple and effective adjunct to help prevent surgical site and post-operative infections."
Dustin Haines, chief commercial officer at Next Science, told OTW the device has three key attributes. "First, broad spectrum efficacy in that the product offers five-plus hours of ongoing protection against bacterial biofilms. Second, ease of use because no secondary rinse is required, which helps reduce surgery time. And third, safety because XPERIENCE is completely non-toxic and extensive testing showed no irritation.”
The company says more than 300 sales agents in a third-party distribution network will sell the device in the US. The network can cover to more than 90% of the US including the 15,000 Hospitals and Ambulatory Surgery Centers that carry out more than 100 million surgical procedures in the U.S. each year.
Initially, the company says it plans to focus on shoulder, hip, knee, trauma and podiatry applications.
Next Science was established in 2012, with a primary focus on the development and continued commercialization of its proprietary Xbio technology "to reduce the impact of biofilm-based infections in human health." Xbio, according to the company, is a "unique, non-toxic technology with proven efficacy in eradicating both biofilm based and free-floating bacteria." The company's research and development center is located in Jacksonville, Florida.