Device Dossier

Genta-Protec - Collagen haemostatic agent, antimicrobial

Device Dossier for Genta-Protec - Collagen haemostatic agent, antimicrobial (Collagen haemostatic agent, antimicrobial, Class III, sponsor Device…

Intended purpose

An absorbable haemostatic agent intended to assist in the control of capillary bleeding in the following surgical procedures ��� Trauma, Orthopaedics, Spinal Surgery, Cardio-thoracic surgery, General surgery and Vascular Surgery. It can be used for haemostasis in venous capillary and minor diffuse arterial bleeding. Although not necessary, it may also be applied in combination with fibrin glue.

Functional description

The device enhances coagulum by a mechanical process, which is then absorbable. The collagen serves as a sponge to take up blood at the surgical site. It concentrates blood and coagulation products via physical absorption, which leads to concentration of platelets within the collagen matrix, formation of a stable blood clot and initiation of coagulation. Fibrinogen is produced enabling haemostasis to be achieved. The sponge is medicated to protect from bacterial contamination.

TGA Public Summary