The FDA has cleared the CleanCision Wound Retraction and Protection System.
Prescient Surgical announced the U.S. Food and Drug Administration (FDA) has cleared the CleanCision Wound Retraction and Protection System for commercialization in the United States.
Developed by surgeons and infection control experts, CleanCision is the first in a new class of advanced technology designed to fight and defend against the most pervasive sources of surgical infection. Utilizing active cleansing technology, CleanCision combines wound protection and irrigation into an intuitive and easy-to-use retraction system that actively, consistently, and continuously clears harmful bacteria that may invade the incision during surgery.
"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," said Dr. 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, Inc. "CleanCision can put more control over the root causes of infection into the hands of surgical teams, enhancing their current infection control protocols," he added.
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. CleanCision is cleared for use in abdominal surgery and may aid in the prevention of wound edge contamination.