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 IIa, sponsor Boston…

Intended purpose

• Treatment of anastomotic leaks or perforations in the upper gastrointestinal tract* by means of negative pressure including intraluminal or intracavitary therapy of paraoesophageal and mediastinal septic focus or localised abscesses endoscopically accessible. • Preventive therapy to reduce the risk of anastomotic leaks in the upper gastrointestinal tract*. *The upper gastrointestinal tract refers to the oesophagus, stomach and duodenum, endoscopically accessible within the range of the overtube length.

TGA Public Summary