The Food and Drug Administration has granted a De Novo request from KCI, an Acelity Company, for its PREVENA Incision Management System. This process provides a pathway to Class I or Class II classification for medical devices for which general controls or general and special controls provide a reasonable assurance of safety and effectiveness, but for which there is no legally marketed predicate device.
The company said in a news statement that PREVENA is 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. The PREVENA disposable negative pressure system is 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. PREVENA Therapy was also indicated to aid in reducing the incidence of seromas.
“PREVENA Incision Management System has a multitude of published studies that consistently demonstrate efficacy in lowering post-surgical wound complications, specifically SSIs,” said R. Andrew Eckert, Chief Executive Officer, KCI in the release.
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.
Ron Silverman, MD, FACS., 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.”
