Systematic Review and Meta-Analysis of Studies Assessing the Safety and Efficacy of the DERIVO® 2heal® Embolization Device.

Abstract

Surface modified flow diverters (FDs) are increasingly being used to reduce thrombogenicity in intracranial aneurysm treatment. The DERIVO® 2heal® Embolisation Device (D2H) is a novel FD with fibrin/heparin-based surface coating intended to reduce thrombogenicity compared to its predecessor, the DERIVO® Embolisation Device (DED). We conducted a systematic review to evaluate the safety and efficacy of D2H. 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 (PRISMA) guidelines. 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% 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. 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, non-standardized follow-up imaging, variable outcome definitions, and selection bias towards complex or previously treated aneurysms. Further prospective studies are required to determine whether D2H provides a clinically meaningful antithrombogenic benefit.