Experience of the New FlowGate² Device as a Balloon Guide Catheter for Ischemic Stroke Intervention

Background: We report the experience of the FlowGate² (FG2) as a new balloon guide catheter in endovascular stroke intervention. Methods: We evaluated the various outcomes and complications of patients with intracranial large artery occlusion undergoing endovascular stroke intervention with FG2 at our center. Baseline characteristics (failure rate of device application, sex, age, risk factors, arterial occlusion sites, and time intervals) were reviewed. Outcomes were evaluated according to National Institutes of Health Stroke Scale score, modified Rankin Scale (mRS) score, number of stent passages required, and Thrombolysis in Cerebral Infarction score. The incidence of hemorrhage, vessel damage, distal emboli, and mortality rate were evaluated as indicators of complications. Results: Overall, 70 patients were enrolled, except the 2 patients with application failure of FG2. Seventy patients with a median age of 69 years were treated with FG2. Arterial occlusion involved the M1 (50%) and M2 (14.3%) segments, internal carotid artery (25.7%), and posterior circulation (10%). Median value of mRS at 90 days was 2.8, and 37 patients (52.8%) had a mRS score ≤2. The recanalization rate in patients with a Thrombolysis in Cerebral Infarction score of 2b or 3 was 91.4%. The hemorrhage rate was 5.7%, but none were symptomatic. In terms of complications, distal emboli occurred in 4.3% of cases. Conclusions: Endovascular stroke intervention with the FG2 is safe and effective with good accessibility and less occurrence of distal emboli. Its trackability, stability, and luminal size make the FG2 suitable for stroke intervention.