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Multicenter Study
. 2025 Mar;35(1):25-34.
doi: 10.1007/s00062-024-01446-8. Epub 2024 Aug 22.

The DERIVO 2 Heal Embolization Device in the Treatment of Ruptured and Unruptured Intracranial Aneurysms: a Retrospective Multicenter Study

Affiliations
Multicenter Study

The DERIVO 2 Heal Embolization Device in the Treatment of Ruptured and Unruptured Intracranial Aneurysms: a Retrospective Multicenter Study

Roland Schwab et al. Clin Neuroradiol. 2025 Mar.

Abstract

Backround: The use of flow diverting stents in the treatment of intracranial aneurysms is associated with a risk of neurological morbidity due to their thrombogenicity. To reduce this risk different surface modifications have been developed. The Derivo 2 Embolization Device (Acandis, Pforzheim, Germany) has proven to be a safe and effective flow diverter. To overcome the risk of thrombo-embolism, the device was modified by adding an anti-thrombogenic fibrin-heparin coating. We aimed to assess the safety and effectiveness of the Derivo 2 heal Embolization Device.

Methods: Retrospective multicenter data from nine German neurovascular centers between February 2022 until December 2023 were used. Patients treated with the Derivo 2 heal Embolization Device for unruptured or ruptured intracranial aneurysms were included. Peri- and postprocedural adverse events, clinical outcomes, and angiographic follow-up results were evaluated.

Results: 84 patients (73.8% female; mean age 58.7 years) with 89 aneurysms (mean size 9.8 mm) were included. 87.6% were located in the anterior circulation. Most of them were sidewall aneurysms (88.8%). 96 flow diverters were used. 99.0% were successfully implanted. An in-stent balloon angioplasty was performed in 6.0% of the cases. An additional coiling was performed in 28.6%. Technical difficulties were present in 12.0% of the cases. Thrombotic events occurred in 4.8% with no neurological sequelae. Mortality and morbidity were 0 and 1.2% respectively. Adequate aneurysm occlusion was achieved in 80.7% with a mean follow-up time of 6.6 months.

Conclusion: The Derivo 2 heal Embolization Device showed a satisfying aneurysm occlusion and safety with a low rate of neurological morbidity.

Keywords: SAH; cerebral aneurysm; endovascular treatment; flow diverter; hemorrhage.

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Conflict of interest statement

Conflict of interest: D. Behme: consultant for Stryker, Acandis, Balt and Phenox; H. Nordmeyer: has received honoraria as a speaker and consulting fees from Acandis and speaker honoraria from Rapid Medical, Microvention, InspireMD, Cerenovus; C. Kabbasch: consultant for Acandis and proctor for Microvention; R. Schwab: consultant for Infinity Neuro, Acandis and Stryker. L. Goertz, M. Kaschner, D. Weiss. C. Loehr, H. Wensing, M. Bester, A. Simgen, A. Kemmling, C. Wendl, E. Fuchs, and M. Thormann declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Patient in their 50s with an incidental, right sided, saccular, paraopthalmic ICA sidewall aneurysm (max. size 14 mm; neck width 4 mm). Pretreatment angiogram in anteroposterior (a) and lateral (b) projection. c Single shot after deployment of a 4 × 15 mm Derivo 2 heal flow diverter (Acandis, Pforzheim, Germany). d Instant unsubstracted angiogram in lateral projection with already intraaneurysmal stasis. ef Full aneurysm occlusion after 6 months with smooth remodeling of the parent vessel

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