FDA Clears PICO Systems for Closed Surgical Incisions to Reduce Wound Complications

The Food and Drug Administration (FDA) has cleared Smith+Nephew’s PICO 7 and PICO 14 Single Use Negative Pressure Wound Therapy (sNPWT) Systems for use on closed surgical incisions to aid in reducing the incidence of superficial and deep incisional surgical site infections (SSIs) for high risk patients in class I and class II wounds, postoperative seroma, and dehiscence.

The PICO 7 and PICO 14 sNPWT Systems include an absorbent sterile dressing connected to a small pump that delivers consistent negative pressure across the wound surface. Wound exudate is managed by the dressing through a combination of absorption and evaporation.

The FDA clearance was based on data from 25 clinical studies (N=5560), spanning a variety of surgical specialties. A meta-analysis of these studies showed that the PICO 7 sNPWT System was effective at reducing the incidence of superficial and deep incisional SSIs for class I and class II wounds when compared with conventional dressings. The incidence of postoperative seroma and dehiscence was also reduced.

These new indications were also cleared for Smith+Nephew’s PICO 7Y System, which treats 2 wounds simultaneously.

Reference

Smith+Nephew’s PICO™ 7 and PICO 14 Negative Pressure Wound Therapy Systems are the first systems indicated to aid in reducing the incidence of both deep and superficial incisional surgical site infections and dehiscence. News release. Smith+Nephew. Accessed January 24, 2022. https://www.prnewswire.com/news-releases/smithnephews-pico-7-and-pico-14-negative-pressure-wound-therapy-systems-are-the-first-systems-indicated-to-aid-in-reducing-the-incidence-of-both-deep-and-superficial-incisional-surgical-site-infections-and-dehiscence-301466351.html