Device Dossier

CAPTOR Thrombectomy Device - Thrombectomy wire-net

Device Dossier for CAPTOR Thrombectomy Device - Thrombectomy wire-net (Thrombectomy wire-net, Class III, sponsor Claro Medtech). ARTG record, intended…

Intended purpose

The Thrombectomy Device is intended to restore blood flow by removing thrombus from large intracranial vessels in patient with ischemic stroke within 8 hours of symptom onset. It is suitable for patients who cannot use intravenous tissue type plasminogen activator (IV t-PA) or IV t-PA treatment failure. The device is designed for use in the neurovasculature such as the internal carotid artery, M1 and M2 segments of middle cerebral artery, basilar, and vertebral arteries. This device includes radiopaque parts (markers).

Functional description

The CAPTOR Thrombectomy Device consists of a Thrombectomy Bracket preassembled within an Introducer Sheath. The bracket comprises a Pushing Wire made of nickel-titanium alloy and a Bracket Part made of platinum-iridium alloy with radiopaque markers at the distal, middle, and proximal locations. The device is surgically invasive, intended for direct contact with the central circulatory system, for short-term use (<24 hours), and is removed immediately after completion of the procedure.

TGA Public Summary