Device Dossier
3D Revascularization Device - Embolectomy/thrombectomy suction catheter
Device Dossier for 3D Revascularization Device - Embolectomy/thrombectomy suction catheter (Embolectomy/thrombectomy suction catheter, Class III, sponsor…
- GMDN category: Embolectomy/thrombectomy suction catheter
Intended purpose
As part of the Penumbra System, the Penumbra 3D Revascularization Device 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) 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 3D Revascularization Device is deployed within the thrombus and then retrieved into the Reperfusion Catheter. The 3D Revascularization Device has an open-body, three-dimensional lattice design and is delivered to the site of occlusion via a compatible inner microcatheter (e.g. with an ID of 0.025 in [0.635 mm]) through the Reperfusion Catheter.