Device Dossier

FlowTriever Retrieval/Aspiration System - Embolectomy/thrombectomy suction catheter

Device Dossier for FlowTriever Retrieval/Aspiration System - Embolectomy/thrombectomy suction catheter (Embolectomy/thrombectomy suction catheter, Class…

Intended purpose

The FlowTriever Retrieval/Aspiration System is indicated and intended purpose for use in the peripheral vasculature and pulmonary arteries for the treatment of intermediate- and high- risk pulmonary embolism in patients 18 years or older deemed medically suitable for mechanical thrombectomy. The FlowTriever Retrieval/Aspiration System is indicated for the non-surgical removal of emboli and thrombi from blood vessels, and injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel. The Triever20 Curve Catheter must be used within the Triever24 Catheter. The FlowTriever Retrieval/Aspiration System is comprised of FlowTriever Catheter and Triever Catheter of varying sizes and compatibility.

Functional description

Retrieval/Aspiration System - FlowTriever Catheter and a Triever Catheter FlowTriever Catheter - coaxial catheter assembly with outer Delivery Catheter and inner catheter with flexible shaft attached to distal self-expanding Nitinol disks. “Y” connector with rotatable hemostatic valve and stopcock attached to outer Delivery Catheter Triever Catheters - single lumen with proximal hemostasis valve and stopcock with flush port. Radiopaque markers are positioned to aid fluoroscopic visualization

TGA Public Summary