Device Dossier

FreeClimb 54 Reperfusion Catheter with Tenzing 5 - Embolectomy/thrombectomy suction catheter

Device Dossier for FreeClimb 54 Reperfusion Catheter with Tenzing 5 - Embolectomy/thrombectomy suction catheter (Embolectomy/thrombectomy suction…

Intended purpose

The Route 92 Medical Full Length Reperfusion System is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral – M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who failed IV t-PA therapy are candidates for treatment.

Functional description

Tenzing catheter: single-lumen, variable stiffness, tapered tip, two radiopaque markers. Proximal end has luer hub. FreeClimb catheter: single-lumen, variable stiffness, radiopaque marker at distal tip. Catheters have hydrophilic coating.

TGA Public Summary