Introduction The Derivo 2 Flow diverter has been previously described for the treatment of intracranial aneurysms. To overcome the risk of in-stent thrombosis and thrombo-embolism the device was modified by adding an anti-thrombogenic fibrin-heparin coating. The fibrin network aims at surface passivation, reduction of inflammatory reactions and endothelial healing. The covalently bound heparin reduces the thrombogenicity by inhibiting the platelet activation and the coagulation cascade.
Aim of Study To assess the safety and effectiveness of the Derivo 2 heal (D2H) Flow diverter.
Methods We performed a retrospective multicenter trial at seven neurovascular centers. Patients treated with the D2H for unruptured or ruptured intracranial aneurysms were included in the study. The primary endpoint was angiographic aneurysm occlusion at six months assessed by the O’Kelly-Marotta scale. Clinical outcome was evaluated after intervention and at six months, with major morbidity defined as modified Rankin Scale scores of 3–5.
Results 17 Patients with available follow-up were subjected to a preliminary analysis. All patients received standard of care antiplatelet therapy according to the respective institutions, with no deviations being reported. Mean aneurysm size was 12 mm. Sufficient aneurysm occlusion (OKM C-D) at six months angiographic follow-up was observed in 88.2%. Device displacement and proximal fish-mouthing occurred in 1 patient with no clinical sequelae. Neither in-stent thrombosis nor in-stent stenosis were detected.
Conclusion The Derivo 2 heal Flow Diverter is a promising antithrombogenic coated device for the treatment of intracranial aneurysms. Early post-interventional and long-term results will provide insight into the effect of antithrombogenicity and endothelial healing.
Disclosure of Interest Hannes Nordmeyer and Daniel Behme received speaker honoraria from Acandis. All other authors have nothing to declare.
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