Device Dossier

Negative-pressure wound therapy tubing set

Device Dossier for Negative-pressure wound therapy tubing set (Negative-pressure wound therapy tubing set, Class IIa, sponsor KCI Medical). ARTG record,…

Intended purpose

The V.A.C. VERALINK CASSETTE is a component of the V.A.C.Ulta Negative Pressure Wound Therapy System which is an integrated wound management system that provides Negative Pressure Wound Therapy with an instillation option. Negative Pressure Wound Therapy in the absence of instillation 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 exudates and infectious material. The instillation option is indicated for patients who would benefit from vacuum assisted drainage and controlled delivery of topical wound treatment solutions and suspensions over the wound bed. The V.A.C.Ulta Negative Pressure Wound Therapy System with and without instillation is indicated for patients with chronic, acute, traumatic, sub acute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure and venous insufficiency), flaps and grafts.

TGA Public Summary