KCI, an Acelity Company, today announced that the U.S. Food and Drug Administration (FDA) has granted the Company’s De Novo request for the PREVENA™ Incision Management System
, the first and only negative pressure medical device indicated to aid in the reduction of superficial surgical site infections (SSIs) in patients at a high risk for post-operative infections in Class I and II wounds. PREVENA™ Therapy was also indicated to aid in reducing the incidence of seromas.
In the United States, SSIs cost the healthcare system up to $10 billion annually. Accounting for 20 percent of all hospital-acquired infections (HAIs), SSIs are the most common and costly.1 Complications from SSIs lead to re-operation and re-admittance, significantly impacting health care costs. SSIs are not only a financial burden, they also take a physical and emotional toll on patients, leading to productivity loss, extended hospital stays, increased health care provider visits and greater financial costs.2,3
“This indication from the FDA is further proof of our intent to bring to market technologies that accelerate healing while reducing the cost of care,” said R. Andrew Eckert, Chief Executive Officer, KCI. “PREVENA™ Incision Management System has a multitude of published studies that consistently demonstrate efficacy in lowering post-surgical wound complications, specifically SSIs. This indication from the FDA demonstrates our commitment to addressing the infection-related burdens faced by healthcare systems and the emotional toll faced by patients.”
Ron Silverman, M.D., F.A.C.S., Chief Medical Officer, KCI, added, “In order to reach this milestone, the FDA conducted a thorough and extensive review of PREVENA™ Therapy clinical data. The FDA’s historic decision to grant this indication speaks to the power of the clinical evidence.”
The PREVENA™ System is the first disposable negative pressure system designed specifically for the management of closed surgical incisions
. It covers and protects the incision from external contamination, while negative pressure removes fluid and infectious material from the surgical incision.
“Each year, more than 150,000 patients in the U.S. suffer with surgical site infections from inpatient surgery across a variety of specialties,” said Dr. Javad Parvizi, MS, MD, FRCS. “Despite measures that have been taken in the last few years, these SSIs pose a serious threat to patients and obstacles for the clinicians who care for them. As surgeons, we need clinically proven solutions that can help lower the incidence rate and provide better outcomes – this new indication from the FDA demonstrates that PREVENA™ Therapy has a role in reducing this burden.”
A meta-analysis including 30 studies from a systematic literature review of 540 publications from a 13 year period entitled, “Meta-Analysis of Comparative Trials Evaluating a Single-Use Closed-Incision Negative-Pressure Therapy System,” recently published in Plastic and Reconstructive Surgery, demonstrated that PREVENA™ Therapy performed significantly better at reducing the incidence of SSIs in comparison to traditional and advanced wound dressings. Randomized controlled trials and observational studies were assessed across specialties, including cardiothoracic, lower extremity, colorectal/abdominal, obstetrics and vascular surgery.4
About PREVENA™ Incision Management System
The PREVENA™ System, launched in 2010, is the first disposable negative pressure system designed specifically for the management of closed surgical incisions. The PREVENA™ System removes fluid away from the surgical incision via the application of -125mmHg continuous negative pressure. When used with legally marketed compatible dressings, PREVENA™ 125 Therapy Unit
and PREVENA PLUS™ 125 Therapy Units
are intended to aid in reducing the incidence of seroma; and in patients at a high-risk for post-operative infections, aid in reducing the incidence of superficial surgical site infection in Class I and Class II wounds.
About KCI, an Acelity Company
KCI, an Acelity Company, is a well trusted brand in advanced wound care. We are a leader in negative pressure wound therapy, providing solutions for both wound healing and surgical management. Our product offerings are available in more than 90 countries and deliver value through solutions that speed healing. KCI is a leader in quality, safety and customer experience and is committed to advancing the science of healing. Headquartered in San Antonio, Texas, KCI employs approximately 4,500 people worldwide.
2. Zimlichman E, Henderson D, Tamir O, et al. Health care-associated infections: a meta-analysis of costs and financial impact on the US health care system. JAMA Intern Med. 2013;173(22):2039-46.
3. Matatov T, Reddy KN, Doucet LD, Zhao CX, Zhang WW. Experience with a new negative pressure incision management system in prevention of groin wound infection in vascular surgery patients. J Vasc Surg. 2013;57(3):791-5.
4. Singh, Devinder P., MD; Gabriel, Allen, MD, FACS; Parvizi, Javad, MS, MD, FRCS; Gardner, Michael J., MD; D’Agostino, Ralph Jr, PhD. Meta-Analysis of Comparative Trials Evaluating a Single-Use Closed-Incision Negative-Pressure Therapy System. Plast Reconstr Surg. 2019 Jan;143:41S-46S.