Novel CleanCision™ Wound Retraction system won FDA clearance for its abdominal wound Retraction and Protection System

Prescient Surgical, Inc., a medical device innovator based in San Carlos, California  just won FDA clearance for commercializing its novel CleanCision wound retraction and protection system.

This system is one of its kind, advanced surgical protection system designed by surgeons and infection control specialists. It is used by surgeons during abdominal surgery to retract the surgical incision, providing easy access to the surgical site while protecting the edges with an impermeable barrier thereby reducing the chances of wound infection. 

The device is placed in the wound and pulled apart, to open the radial fan like expanding system that is suitable for incisions ranging from 7-16 cm. The wound edges are continuously irrigated by an irrigant fluid of surgeon’s choice with the help of gravitational force from an external fluid bag and the excess is drained via a suction connected to the device. The impermeable inner layer of retractor prevents the wound contamination by fluids in the operative field.

Studies have shown a 61% reduction in rates of SSI using this device. The product is initially promoted for abdominal surgery and particularly colorectal surgery, where the risk, frequency and severity of surgical site infection is high, and the need is acute. But, it is useful in other specialties like Oncology and Ob/Gyn also.

The clearance could not have come at better time because "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," says Brant Heise, Managing Director at Summation Health Ventures.

The 2016 Surgical Site Infection updated guidelines, published by the American College of Surgeons and Surgical Infection Society, report that the risk of SSI is generally 2 to 5 percent with an estimated 160,000 to 300,000 SSIs occurring annually in the U.S.² The rate of SSI can be as high as 15 to 30 percent in certain high-risk, clean-contaminated, and contaminated procedures such as colorectal surgery.³ National focus on SSI is increasing due to public reporting of surgical site infection rates and significant financial penalties imposed on hospitals, brought about by the Centers for Medicare and Medicaid Service's (CMS) Hospital-Acquired Condition Reduction Program.

Product information

Prescient Surgical News Release