Device Dossier

SURGIFLO™ Haemostatic Matrix Kit with Thrombin, MS0016 - Gelatin haemostatic agent

Device Dossier for SURGIFLO™ Haemostatic Matrix Kit with Thrombin, MS0016 - Gelatin haemostatic agent (Gelatin haemostatic agent, Class III, sponsor…

Intended purpose

Surgiflo is indicated in surgical procedures (other than ophthalmic) as an adjunct to haemostasis when control of bleeding ranging from oozing to spurting by ligature or other conventional methods is ineffective or impractical.

Functional description

Single use device consisting of porcine-derived SURGIFLO™ Haemostatic Matrix and plasma-derived human thrombin combined at the point of clinical use. The Gelatin Matrix provides an environment for platelets to adhere and aggregate within, building on the patient's coagulation cascade. The patient's endogenous thrombin is activated and converts fibrinogen into an insoluble fibrin clot. The thrombin component provides an ancillary effect to the innate haemostatic property of the Gelatin Matrix.

TGA Public Summary