Device Dossier

Trim-Flex Dual Stage Venous Drainage Cannula - Cannula, venous

Device Dossier for Trim-Flex Dual Stage Venous Drainage Cannula - Cannula, venous (Cannula, venous, Class III, sponsor Device Technologies). ARTG record,…

Intended purpose

Dual drainage venous return cannulae are indicated for venous cannulation so that extracorporeal circulation of the venous blood to a heart-lung machine may be achieved, for a duration of < 6 hours. They are also indicated for coronary bypass procedures where single tube venous drainage from the right atrium only is ordinarily contraindicated because of diminished caval return due to intraoperative manipulation of the heart.

Functional description

The Venous Drainage Cannulae provide a means of draining deoxygenated blood during cardiopulmonary bypass (CPB) procedure. CPB is performed on patients who undergo cardiac surgeries and the surgery requires their non-beating heart. The device is inserted via superior and inferior vena cava access, to maintain oxygenation of the blood (by means of draining deoxygenated blood during CPB) while the patient is not oxygenating naturally. The cannula is intended to be used in short tem (<6 hours).

TGA Public Summary