FDA clears Prescient Surgical’s wound retraction device
The US Food and Drug Administration (FDA) has cleared Prescient Surgical’s CleanCision Wound Retraction and Protection System for commercialisation in the country.
Indicated for abdominal surgery, CleanCision is part of a new advanced technology class being developed to protect from the most prevalent sources of surgical infection.
The system uses active cleansing technology and combines wound protection with irrigation in an intuitive retraction system designed for active, consistent and continuous clearance of harmful bacteria that might invade the surgical incision.
According to the firm, CleanCision reverses and minimises these infection sources and clears the bacteria throughout surgery.
Prescient Surgical co-founder Dr Mark Welton said: “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 healthcare costs for hospitals.
“CleanCision can put more control over the root causes of infection into the hands of surgical teams, enhancing their current infection control protocols.”
The easy-to-use system facilitates access to the surgical site and uses a surgeon-selected sterile irrigant solution to clear contamination.
CleanCision continuously and consistently irrigates the wound edge, while contaminants are removed through suction.
Prescient Surgical co-founder, president and CEO Jonathan Coe said: “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.
“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 utilised in their procedures.”