Long-term Safety and Efficacy of the Derivo Embolization Device in a Single-center Series.

ABSTRACT

PURPOSE: This study analyzes the long-term clinical and angiographic outcomes of the Derivo Embolization Device (DED), an advanced flow diverter device with an electropolished surface, for the treatment of intracranial aneurysms. METHODS: A consecutive series of 101 patients (mean age 58 years, 72% female) treated with the DED for 122 aneurysms at a single center between 2017 and 2023 was retrospectively analyzed for major (change in National Institutes of Health Stroke Scale [NIHSS] score ≥ 4 points) and minor (change in NIHSS score < 4 points) neurological events, procedural morbidity (increase of at least one point on the modified Rankin Scale), and angiographic results. RESULTS: There were 14 (11%) recurrent aneurysms, 15 (12%) ruptured aneurysms, 26 (21%) posterior circulation aneurysms and 16 (13%) fusiform or dissecting aneurysms. Device deployment failed in 1 case (1%). Procedure-related symptomatic procedural complications consisted of 2 (2%) major events (1 major stroke and 1 vessel perforation with intracranial hemorrhage and infarction) and 6 minor events (6 minor strokes). Procedural morbidity was 5%. There were no late ischemic or hemorrhagic events during follow-up. Complete and favorable aneurysm occlusion was achieved in 54% (40/74) and 62% (46/74) at a mean of 5 months, 71% (27/38) and 87% (33/38) at a mean of 12 months, and 76% (25/33) and 97% (32/33) at a mean of 35 months, respectively. CONCLUSION: The results demonstrate progressive aneurysm occlusion beyond 12 months after DED implantation with an almost 100% favorable occlusion rate. Procedural morbidity was low and there were no late complications.