Device Dossier

Negative-pressure wound therapy system foam dressing

Device Dossier for Negative-pressure wound therapy system foam dressing (Negative-pressure wound therapy system foam dressing, Class IIb, sponsor KCI…

Intended purpose

The V.A.C. Dressing is a component of the V.A.C. Therapy System. The V.A.C. Therapy System is an integrated wound management system for use in acute, extended and home care settings. It is intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation, and perfusion, and by removing exudate and infectious material. Open wound types include: chronic, acute, traumatic, subacute and dehisced wounds, partial thickness burns, ulcers (such as diabetic, pressure or venous insufficiency), flaps and grafts. When used on closed surgical incisions, it is also intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.

TGA Public Summary