San Carlos, Calif.-based Prescient Surgical, Inc., a medical device company dedicated to developing advanced tools and technologies to prevent surgical-site infections (SSIs), announced that the U.S. FDA has cleared the CleanCision Wound Retraction and Protection System for commercialization in the United States.
Developed by surgeons and infection control experts, CleanCision combines wound protection and irrigation into a retraction system that has been shown to reverse and reduce the pervasive sources of surgical infection—clearing harmful bacteria throughout surgery when the threat of wound contamination is at its highest.
“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,” says Mark Welton, MD, chief medical officer, Fairview Health Services, former Harry A. Oberhleman Jr., professor of surgery and chief of colon and rectal surgery at Stanford University School of Medicine, Palo Alto, Calif., and cofounder of Prescient Surgical.
“CleanCision can put more control over the root causes of infection into the hands of surgical teams, enhancing their current infection control protocols,” he adds.
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, also spoke out about the product clearance, commenting: “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.”
“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,” Suh adds.
Easily deployed to retract and protect the wound site, CleanCision provides access to the surgical site and uses a sterile irrigant solution, selected by the surgeon, to clear contamination invading the surgical incision. The wound edge is continuously and consistently irrigated while suction removes contaminants throughout the surgery.
Finally, CleanCision is cleared for use in abdominal surgery and may aid in the prevention of wound edge contamination.