Penumbra System Reperfusion Catheter ACE 64 - Embolectomy/thrombectomy suction catheter

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Available from:

Penumbra Neuro Australia Pty Ltd

Class:

Class III

Manufactured by:

Penumbra Inc One Penumbra Place, Alameda, CA, 94502 United States Of America

Therapeutic area:

58173 - Embolectomy/thrombectomy suction catheter

Therapeutic indications:

The Reperfusion Catheter is introduced through a guide catheter or long femoral sheath and into the intracranial vasculature and guided over a neurovascular guidewire to the site of the primary occlusion. This device is a variable stiffness catheter with a proximal shaft of stainless steel wire and a distal shaft coiled with Nitinol wire. It is used with an Aspiration Pump and Separator to aspirate and assist with thrombus removal from an occluded vessel. 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.

Authorization status:

A

Authorization date:

2017-07-26