Device Dossier
Penumbra System RED Reperfusion Catheters - Embolectomy/thrombectomy suction catheter
Device Dossier for Penumbra System RED Reperfusion Catheters - Embolectomy/thrombectomy suction catheter (Embolectomy/thrombectomy suction catheter,…
- GMDN category: Embolectomy/thrombectomy suction catheter
Intended purpose
The Penumbra System RED Reperfusion Catheters are designed to remove thrombus and restore blood flow in the neurovasculature using aspiration. As part of the Penumbra System, the RED 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. As part of the Penumbra System, the Penumbra Sterile Aspiration Tubing is indicated to connect the Penumbra Reperfusion Catheters to the Penumbra Aspiration Pump
Functional description
The Penumbra System RED Reperfusion Catheters are designed to remove thrombus from the vasculature using continuous aspiration. The RED Reperfusion Catheter is introduced through a guide catheter or sheath and into the intracranial vasculature and guided over a guidewire to the site of the primary occlusion. It is used with Aspiration Tubing to target aspiration from the aspiration pump directly to the thrombus. RED Catheters are available prepackaged with Aspiration Tubing.