Kinetic Concepts has been given 510(k) clearance from the US Food and Drug Administration (FDA) for its Prevena Incision Management System, a negative-pressure wound therapy product.
The system removes exudate and potentially infectious material from surgical incisions, providing a clean and protected postoperative wound.
Managing incisions after surgery is essential to prevent wound complications.
The device is portable and designed for single-patient use.
The Prevena System has been available in Canada and Europe since spring 2010 and is expected to be available to US hospitals in early July.
