Device Dossier
Reperfusion Catheter + SENDit Technology - Embolectomy/thrombectomy suction catheter
Device Dossier for Reperfusion Catheter + SENDit Technology - Embolectomy/thrombectomy suction catheter (Embolectomy/thrombectomy suction catheter, Class…
- GMDN category: Embolectomy/thrombectomy suction catheter
Intended purpose
The Penumbra System is designed to remove thrombus and restore blood flow in the neurovasculature using aspiration. As part of the Penumbra System, the Reperfusion Catheters and Separators 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. SENDit Technology assists in the delivery of the Reperfusion Catheter to the target site and is removed from the Reperfusion Catheter prior to aspiration.
Functional description
The Penumbra Reperfusion Catheter is used with the Aspiration Pump to aspirate thrombus from an occluded vessel. SENDit Technology is an optional accessory to assist in the delivery of the Reperfusion Catheter to the target site and is removed from the Reperfusion Catheter prior to aspiration. SENDit Technology may be used with its prepackaged Reperfusion Catheter to facilitate access to the primary occlusion. The SENDit Technology compatibility is limited to its prepackaged Reperfusion Catheter