Device Dossier

MAX Reperfusion Catheter - Catheter, embolectomy

Device Dossier for MAX Reperfusion Catheter - Catheter, embolectomy (Embolectomy/thrombectomy suction catheter, Class III, sponsor Penumbra Neuro). ARTG…

Intended purpose

As part of the Penumbra System the reperfusion catheters are 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 fail IV t-PA therapy are candidates for treatment.

Functional description

The Penumbra System was designed to remove thrombus from large intracranial vessels by aspirating the proximal side of the thrombus. The Reperfusion Catheter is introduced through a guide catheter or long femoral sheath and into the intracranial vasculature and guided over a guidewire to the site of the primary occlusion. The Penumbra Reperfusion Catheter is used in parallel with the Penumbra Separator and an aspiration source to separate the thrombus and aspirate it from the occluded vessel.

TGA Public Summary