Systematic Review and Meta-Analysis of Studies Assessing the Safety and Efficacy of the DERIVO 2heal Embolization Device
Abstract
Objective: Surface-modified flow diverters are increasingly being used to reduce thrombogenicity in intracranial aneurysm treatment. The DERIVO 2heal Embolisation Device (D2H) is a novel flow diverter with fibrin-based/heparin-based surface coating intended to reduce thrombogenicity compared to its predecessor, the DERIVO Embolisation Device. We conducted a systematic review to evaluate the safety and efficacy of D2H.
Methods: We searched PubMed/MEDLINE, Embase, Web of Science, and Scopus databases from inception to January 6, 2025, in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.
Results: Five retrospective studies encompassing 176 intracranial aneurysms (16 [9.1%] ruptured) were included. Adjunctive coiling was used in 21% and balloon angioplasty in 7.7% of cases. The pooled rate of periprocedural ischemic or hemorrhagic complications was 7.1% (95% confidence interval [CI]: 3.9%-12%), and the technical complication rate was 9.3% (95% CI: 5.9%-14%). Complete angiographic occlusion at mid-term follow-up (∼6 months) was achieved in 79% of aneurysms (95% CI: 72%-85%), and no treatment-related mortality was reported.
Conclusions: D2H demonstrated acceptable angiographic occlusion rates, but its safety profile has not been shown to be superior to established uncoated devices. Findings are limited by study heterogeneity, nonstandardized follow-up imaging, variable outcome definitions, and selection bias toward complex or…
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Evidence Hub reads this as a meta-analysis, done in people. Its evidence level is 1 of 5 (Highest · pooled evidence). Pooled evidence from several studies sits at the top of the evidence pyramid.
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