Previously, experience with the Enterprise vascular reconstruction device (Codman) has only been described in studies as a bailout procedure after primary stenting for acute ischaemic stroke with the Wingspan stent delivery system (Boston Scientific).
Elad L Levy, Department of Neurosurgery, School of Medicine and Biomedical Sciences, University at Buffalo, State University of New York, Buffalo, USA) and colleagues therefore investigated the safety and effectiveness of the Enterprise for primary stenting for acute ischaemic stroke. They report their findings in the Journal of NeuroInterventional Surgery.
The study was a US Food and Drug Administration investigational device exemption prospective cohort study.
The authors report that 20 patients who presented with acute ischaemic stroke due to intracranial large vessel occlusion were treated with the Enterprise within eight hours of symptom onset. The primary outcome was Thrombolysis In Myocardial Infarction (TIMI) flow of ≥2. Perioperative safety was measured by major complication incidence within 30 days of revascularisation and a secondary outcome measure was 30-day modified Rankin Scale score.
According to Levy et al, recanalisation to TIMI score 2 (n=6) or 3 (n=12) flow was achieved in 18 patients (90% revascularisation rate). Three major complications occurred (15%) and good outcome (modified Rankin Scale score) was achieved in 10 patients (50%).
“In this prospective study, the Enterprise stent was found to be a safe and effective revascularisation tool in the setting of acute ischaemic stroke,” the authors conclude.
Levy adds that the favourable qualities that make the Enterprise suitable for primary stenting in ischaemic stroke are effective navigability, the ability to retrieve after partial deployment and reasonable radial force.