The FDA has given Kinetic Concepts, Inc. 510(k) clearance for its Prevena Incision Management System. The system, which has been available in Canada and Europe since earlier this year, uses negative pressure to aid in the healing process for surgical wounds. KCI plans to make the new system available to US customers next month.
From the press release:
The Prevena™ System is indicated for use over clean, closed incisions that continue to drain following sutured or stapled closure. It acts by:
Removing exudate and potentially infectious material Helping hold the edges of the incision together Protecting the surgical site from external contamination Providing a clean, protected postoperative wound environment