Surgical device spin-out Prescient Surgical said today it won FDA clearance for its CleanCision wound retraction and protection system.
The San Carlos, Calif.-based company, which was spun out of the Stanford Byers Center for Biodesign in 2012, said its CleanCision device is the 1st in a new category of irrigating wound protection devices, as classified by the FDA.
Such devices are designed to provide access to the surgical site while protecting the incision with an impermeable barrier to defend against direct contamination.
“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. CleanCision can put more control over the root causes of infection into the hands of surgical teams, enhancing their current infection control protocols,” co-founder Dr. Mark Welton of Fairview Health Services said in a prepared statement.
“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,” co-founder Dr. Insoo Suh of the University of California San Francisco said in a prepared release.
Prescient Surgical said the CleanCision device is designed to be easily deployed, and provides access to the surgical site using sterile irrigant solution to clear contamination. Wound edges are continuously and consistently irrigated while suction removes contaminants, the company 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 utilized in their procedures. The result is an intuitive system that readily integrates into surgical workflow,” co-founder, prez & CEO Jonathan Coe said in a press release.
In January, Prescient Surgical said it won de novo clearance from the FDA for its CleanCision.
At DeviceTalks Boston, Tyler Shultz will give attendees an inside look at Theranos and how he was able to sound the alarm after he realized the company was falling apart. Shultz will take attendees behind the story that everyone is talking about: the rise and fall of Elizabeth Holmes and her diagnostic company, Theranos.
Join Shultz and 1,000+ medical device professionals at the 8th annual DeviceTalks Boston.