Background: The safety and probable benefit of the PulseRider® (Pulsar Vascular, San Jose, CA) for the treatment of broad-necked, bifurcation aneurysms was studied in the context of the prospective, non-randomized, single arm clinical trial - the Adjunctive Neurovascular Support of Wide-neck aneurysm Embolization and Reconstruction Trial (ANSWER).
Objective: We present the results of the United States cases employing the PulseRider® device as part of the ANSWER clinical trial.
Methods: Aneurysms treated with the PulseRider® device among U.S. sites enrolling in the ANSWER trial were prospectively studied and the results are summarized. Aneurysms arising at either the carotid terminus or basilar apex that were relatively broad necked were considered candidates for inclusion into the ANSWER study.
Results: 34 patients were enrolled (29 female and 5 male) with a mean age of 60.9 years (27 basilar apex and 7 carotid terminus). Mean aneurysm height ranged from 2.4 to 15.9 mm with a mean neck size of 5.2 mm (range 2.3 - 11.6 mm). In all patients the device was delivered and deployed. Immediate Raymond I or II occlusion was achieved in 82.4% and progressed to 87.9% at six month follow up. A modified Rankin Score of 2 or less was seen in 94% of patients at 6 months.
Conclusions: The results from the U.S. cases of the ANSWER trial demonstrate that the Pulse Rider® device is safe and effective as for the treatment of bifurcation aneurysms arising at the basilar apex or carotid terminus. As such, it represents a useful addition to the armamentarium of the neuroendovascular specialist.