Table 6

Primary endpoints

EndpointAnalysis cohort (Subjects)
Primary Effectiveness94.0% (110/117) (88.1%, 97.6%)
Procedure Completed Robotically94.0% (110/117)
Unplanned Manual Conversion6.0% (7/117)
Device Malfunction1.7% (2/117)
Control Console Failure0.9% (1/117)
Cassette Failure0.9% (1/117)
Procedural Limitation4.3% (5/117)
Loss of Working Length2.6% (3/117)
Use of Off-label Microcatheter0.9% (1/117)
Coil Deployment0.9% (1/117)
Primary Safety3.4% (4/117) (0.9%, 8.5%)
Stroke (Major)1.7% (2/117)
Intraprocedural Aneurysm Rupture1.7% (2/117)