Device Dossier

Angiography contrast medium injection system, line-powered, mobile

Device Dossier for Angiography contrast medium injection system, line-powered, mobile (Angiography contrast medium injection system, line-powered,…

Intended purpose

The device allows the intravascular injection of CO2, with precise volume dose and injection pressure, to perform Automated Carbon Dioxide Angiography (ACDA). ACDA is contraindicated in supradiaphramgmatic arterial studies, cerebral vessels, Coronary arteries, pulmonary insufficiency, presence of interarterial or interventricular communication (contraindication for venous studies only, due to the potential risk of paradoxical embolism) pulmonary arteriovenous malformation, nitric oxide anaethesia.

TGA Public Summary