Surgical device spin-out Prescient Surgical said today it won de novo clearance from the FDA for its CleanCision wound retraction and protection system designed to cleanse and protect surgical wound edges.
The San Carlos, Calif.-based company said its CleanCision device is the 1st in a new category of irrigating wound protection devices, as classified by the FDA. Such devices are designed to provide access to the surgical site while protecting the incision with an impermeable barrier to defend against direct contamination.
“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,” Summation Health Ventures managing director Brant Heise said in a prepared statement.
Prescient Surgical, which was spun out of the Stanford Byers Center for Biodesign in 2012, said it hopes to launch the CleanCision device this year.
“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 CEO Jonathan Coe said in a press release.