KCI, now a part of the Acelity Company, has announced that its PREVENA negative pressure incision management system is the first to receive FDA’s indication to help with reducing superficial surgical site infections in those at high risk of post-op infections. The approval comes under the FDA’s de novo pathway that was designed to bring forward new technologies that may help address important medical necessities.
The PREVENA system is a disposable product that is used to cover and protect a wound, and it negative pressure force of -125mmHg helps to drain the wound of fluids. It was previously approved by the FDA to prevent seromas.
“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,” in a statement 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.”
Some details on the studies that led to the approval, according to KCI:
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.
Product page: PREVENA Incision Management System…