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

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.
Competing Interests: Declarations Conflict of interest TL previously served as proctor for MicroVention Inc./Sequent Medical (Aliso Viejo, CA, USA), CERUS Endovascular (Fremont, CA, USA), Phenox (Bochum, Germany), Stryker (Kalamazoo, MI, USA), and Medtronic (Dublin, Ireland). FD serves as consultant/ proctor for MicroVention Inc./Sequent Medical, Balt (Irvine, CA, USA), Cerenovus/Johnson&Johnson (Irvine, CA, USA); received speakers honoraria from Cerenovus/ Johnson&Johnson, Acandis (Pforzheim, Germany), Asahi (Tokyo, Japan), Q`Apel (Fremont, CA, USA), Penumbra (Alameda, CA, USA), Medtronic, Stryker; received scientific grants from Cerenovus/ Johnson&Johnson. CK serves as consultant for Acandis GmbH and as proctor for MicroVention Inc./Sequent Medical. DZ is on the speaker’s bureau of Philips (Amsterdam, the Netherlands) and lecturer for Amboss GmbH (Cologne, Germany). The other authors declare that they have no competing interests. Ethical standards For this article no studies with human participants or animals were performed by any of the authors. All studies mentioned were in accordance with the ethical standards indicated in each case.
(© 2024. The Author(s).)