Multicenter clinical experience in over 125 patients with the Penumbra Separator 3D for mechanical thrombectomy in acute ischemic stroke.

Background: The aim of this study was to assess reperfusion and clinical outcome of treatment with the self-expanding retrievable Separator 3D in revascularization of acute ischemic stroke. The three-dimensional (3D) device secures thrombus with direct aspiration and supports debulking of the clot.

Methods: At two centers, 129 consecutive stroke patients with National Institutes of Health Stroke Scale (NIHSS) scores ≥5 were treated with mechanical thrombectomy using the Separator 3D as a component of the Penumbra System within 8 h of symptom onset; modified Treatment in Cerebral Infarction (mTICI) revascularization scores, NIHSS score on admission and discharge, mortality rates, and modified Rankin Scale (mRS) outcomes at 90 days were evaluated.

Results: A total of 129 vessels in 129 patients were treated. Occlusions were located in the middle cerebral artery (MCA, 48%), internal carotid artery (ICA, 33%), cervical ICA-MCA (3%), and vertebrobasilar arteries (16%). Intravenous thrombolytic therapy with recombinant tissue plasminogen activator was given to 78% of patients. Median NIHSS was 15 prior to treatment. Reperfusion to mTICI 2b or 3 was successful in 96/129 (74%) target arterial lesions, with more than half of cases (51%) achieving mTICI 3. The mean time from arterial puncture to revascularization was 65 min. At 90 days, the symptomatic intracranial hemorrhage rate was 4%, all cause mortality was 32%, and 43/99 patients (43%) achieved functional independence with an mRS score of ≤2.

Conclusions: The results suggest that the Separator 3D enables safe and effective revascularization of occluded large arteries in acute stroke intervention, leading to a high rate of functional independence at 90 days.