Prescient Surgical has secured de novo clearance from the US Food and Drug Administration’s (FDA) Center for Devices & Radiological health for its CleanCision wound retraction and protection system.
The system has been approved for surgical wound edge protection, retraction, and continuous cleansing with a sterile irrigant solution. It also enables to prevent wound edge contamination.
The device is said to offer access to the surgical site while protecting the incision with an impermeable barrier, helping to defend against direct contamination.
CleanCision will also facilitate intraoperative delivery of a sterile irrigant solution of the surgeon's choice to the wound edge.
The device aggregates two independent strategies, including wound irrigation and wound protection, to prevent surgical site infection.
The company intends to commercialize CleanCision system in this year.
Prescient Surgical CEO Jonathan Coe said: "This news from the FDA marks a crucial milestone for Prescient Surgical and validates the hard work put in by our team and clinical partners towards our mission of reducing the risk of SSI.
“Most importantly, we can now look toward extending the promising results we've seen in recent clinical trials to the broader patient population.”
Prescient Surgical is a spin off the Stanford Byers Center for Biodesign, which involved in the development of solution for surgical site infection that is associated with significant morbidity and mortality.