- San Antonio, Texas-based wound therapeutics brand KCI Thursday said its Prevena Incision Management System is now indicated for the reduction of seromas and superficial surgical site infections in patients at high risk for post-operative infections in clean (Class I) and clean-contaminated (Class II) wounds, based on a De Novo clearance granted by FDA in April.
- The device is a disposable system meant to cover and protect surgical incisions from external contamination, using negative pressure to remove fluid and infectious material from the incision.
- Acelity, KCI's parent company, was acquired by 3M last week in a deal valued at $6.7 billion.
KCI has sold its Prevena system since 2010, when it originally received 510(k) clearance to maintain a closed environment and remove exudate from surgical incisions that continued to drain following sutured or stapled closure.
Under the reclassification order issued by FDA, the agency is labeling the new class of products created by the De Novo clearance "Negative pressure wound therapy device for reduction of wound complications," which the agency describes as devices involving a powered suction pump that applies negative pressure to the wound, thereby removing fluids.
The device type will be regulated under Class II special controls and is intended to be used with wound dressings. The classification excludes devices intended for organ space wounds, FDA said.
Surgical site infections are the most common type of hospital-acquired infection and the most costly, according to the American College of Surgeons. While the infections are associated with hospital stays extended by approximately 10 days and an increase of $20,000 in cost per hospital admission, the group says as many as 60% of these infections are considered preventable.
A meta-analysis published in January in Plastic and Reconstructive Surgery found a statistically significant reduction in incidence of surgical site infections in patients receiving closed incision negative pressure therapy compared to those only receiving traditional wound dressings. KCI said the study covered 540 publications from a 13-year period and assessed patients across medical specialties, including cardiothoracic, abdominal and vascular surgery.
The KCI brand is marketed by Acelity, which 3M announced last week it would add to its medical solutions business in a deal worth $6.7 billion. 3M said privately-held Acelity had revenues of $1.5 billion in 2018.