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Devices Surgery FDA

 News Release - December 19, 2017

Prescient Surgical Receives FDA 510(k) Clearance for Its Novel CleanCision(TM) Wound Retraction and Protection System

Surgeons and infection control experts develop new class of advanced technology to fight and defend against surgical site infection--the most common and costly type of hospital-acquired infection in the United States

SAN CARLOS, Calif., Dec. 19, 2017 -- (Healthcare Sales & Marketing Network) -- Prescient Surgical, Inc., a medical device innovator dedicated to developing advanced tools and technologies to prevent surgical site infections (SSIs), announced that the U.S. Food and Drug Administration (FDA) has cleared the CleanCision™ Wound Retraction and Protection System (CleanCision™ 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.

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.1

"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.

"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, MD, 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, Inc. "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," he added.

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.

"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, Inc. "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," he added.

Hospitals can acquire CleanCision through the company's Early Access Program, developed to help surgical teams implement and measure the impact of the device as part of their infection reduction programs. For more information please visit www.prescientsurgical.com.

Background on Surgical Site Infection

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.

About Prescient Surgical

Based in San Carlos, Calif., Prescient Surgical, Inc. is a medical device innovator that makes advanced tools and technologies to fight and defend against the sources of surgical site infection. With technological innovation, greater awareness, and ongoing collaboration with hospitals around best practices, Prescient Surgical is dedicated to making surgery safer, improving the patient experience with surgery, and significantly improving post-operative outcomes. The company was conceived at the Stanford Byers Center for Biodesign and accelerated at Stanford StartX Med and the Fogarty Institute for Innovation.

For more information on CleanCision™ and Prescient Surgical, visit http://www.prescientsurgical.com/ and follow on Twitter at @PrescientSurg

1 H. T. Papaconstantinou et al., "A Novel Surgical Device Combining Continuous Intraoperative Wound Irrigation and Barrier Protection Markedly Reduces Incisional Contamination in Colorectal Surgery," presented at the American Society of Colon and Rectal Surgeons 2017 Annual Scientific Meeting, June 10–14, 2017.

2 K. A. Ban et al., "Surgical Site Infection Guidelines, 2016 Update," American College of Surgeons and Surgical Infection Society, Journal of the American College of Surgeons, no. 224 (2017): 59–74.

3 A. Zywot et al., "Bundles Prevent Surgical Site Infections After Colorectal Surgery: Meta-Analysis and Systematic Review," Journal of Gastrointestinal Surgery 21, no. 11 (November 2017): 1915–1930.


Source: Prescient Surgical

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