FDA clears device for protecting against surgical site infection

Medical device company Prescient Surgical announced that the FDA has issued 510(k) clearance for commercialization of its novel device designed to protect against surgical site infection during abdominal surgery.

Developed by surgeons and infection control experts, the CleanCision Wound Retraction and Protection System uses “active cleansing technology” that combines wound protection and irrigation in a user-friendly retraction system for continuous clearing of harmful bacteria that could invade the incision during surgery, according to a press release.

“Unlike traditional methods, which cannot continuously and consistently clear contamination from the surgical site, CleanCision has been shown to reverse and reduce these pervasive sources of infection, clearing harmful bacteria throughout surgery when the threat of wound contamination is at its highest,” per the press release.

Surgical site infection (SSI) is the most common and costly type of hospital-acquired infection in the U.S., with SSI rates as high as 15% to 30% in high-risk procedures like colorectal surgery, the release noted.

“The threat of incision infection in high risk abdominal surgery presents a constant threat with the potential to adversely impact patient outcomes and drive up health care costs for hospitals,” Mark Welton, MD, chief medical officer at Fairview Health Services, former Harry A. Oberhleman Jr. professor of surgery and chief of colon and rectal surgery at Stanford University School of Medicine in Palo Alto, Calif., and cofounder of Prescient Surgical, said in the press release. “CleanCision can put more control over the root causes of infection into the hands of surgical teams, enhancing their current infection control protocols.”

To use the device, surgeons can deploy it to retract and protect the wound site. It provides access to the surgical site, and the surgeon can select a sterile solution to continuously irrigate the wound edge while suction removes contaminants throughout the procedure.

“While infection control workflow and processes steadily improve year after year, the tools and technologies that should aid those efforts simply haven’t kept pace,” Insoo Suh, MD, assistant professor of surgery, division of general surgery, endocrine surgery section, University of California San Francisco and attending, endocrine, and general surgery, San Francisco VA Medical Center, and cofounder of Prescient Surgical, said in the press release. “We are seeing that a proactive approach to clearing contamination during surgery has the potential to better protect patients from infection and help hospitals address the increased health care costs that result from surgical site infections, such as extended hospital stays, re-hospitalization and rising infection rates that trigger penalties from CMS.”

“We are initially focusing on abdominal surgery and particularly colorectal surgery, where the risk, frequency and severity of surgical site infection is high and the need is acute,” Jonathan Coe, cofounder, president and CEO of Prescient Surgical, said in the press release. “Our team collaborated closely with leading hospitals in abdominal surgery to create a technology platform and product that could be used in the full range of open and minimally invasive approaches utilized in their procedures. The result is an intuitive system that readily integrates into surgical workflow.”

Hospitals can acquire the product through Prescient Surgical’s early access program, according to the press release.

Disclosures: Coe, Suh, and Welton are all employed by Prescient Surgical.