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FDA approves CleanCision wound retraction and protection system

Wed, 01/10/2018 - 18:15
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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

The FDA has cleared Prescient Surgical’s CleanCision wound retraction and protection system for commercialisation in the US. Developed by surgeons and infection control experts, CleanCision is a new class of advanced technology designed to fight and defend against the most pervasive sources of surgical infection. Utilising 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.

"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," said Jonathan Coe, cofounder, president and CEO of Prescient Surgical. "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. The result is an intuitive system that readily integrates into surgical workflow," he added.

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.

"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, 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, CA, 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.”

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. CleanCision is cleared for use in abdominal surgery and may aid in the prevention of wound edge contamination.

"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," said Dr Insoo Suh, 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. "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.”