Table 2

Primary endpoint analysis

EndpointFrequency
Safety endpoints
 Device-related vessel perforation or dissection requiring clinical intervention0 (0%)
 Device-related vessel thrombosis or occlusion0 (0%)
 Device-related vasospasm with permanent neurological manifestation0 (0%)
 Device malfunction resulting in permanent neurologic injury or death0 (0%)
Effectiveness endpoints
 Navigation through the neurovasculature25/25 (100%)
 Contrast delivered successfully as intended7/7 (100%)
 Intended therapy delivered successfully with Bendit14/18 (77.8%)