Stanford University spinout, Prescient Surgical, earned de novo clearance for its wound retraction and protection system, designed to combat surgical site infection. The company plans the launch the device this year.
The CleanCision device combines wound irrigation and protection, two strategies shown to prevent infection at the surgical site. It is the first of its kind to be cleared by the FDA, which created the classification “irrigating wound retractor device.”
It is indicated for abdominal surgery, during which it retracts the incision, irrigates the wound edge and provides access to the abdominal cavity. The double-walled sheath delivers a sterile irrigant solution and removes fluid from the wound edge.
“This news from the FDA marks a crucial milestone for Prescient Surgical … we can now look toward extending the promising results we've seen in recent clinical trials to the broader patient population," Prescient Surgical CEO Jonathan Coe said in a statement.
Spun out of Stanford’s Byers Center for Biodesign in 2012, Prescient’s mission is to bring down healthcare costs by targeting the risk of surgical site infection, which is linked to “significant morbidity and mortality.” While the risk of surgical site infection generally hovers around 2 to 5%, the company said, it is focusing on high-risk gastrointestinal procedures, such as colorectal surgery, where the risk can be much higher.
"Hospitals are increasingly focusing on infection control to improve patient care as a primary goal. Prescient's success with the CleanCision device bodes well for providers driven towards the 'triple aim' of quality of care, patient satisfaction, and reduced costs."