First clinical experience with the Derivo 2heal embolization device for the treatment of intracranial aneurysms

Objective The development of new flow-diverting devices with antithrombotic coatings may result in an improved safety profile, particularly a reduction in ischaemic stroke rates. The aim of this study was to evaluate our initial experience with the recently introduced coated Derivo® 2heal® Embolization Device (Acandis, Pforzheim, Germany). Methods This is a retrospective, single-centre analysis of patients with intracranial aneurysms undergoing Derivo® 2heal® Embolization Device treatment. Patient and aneurysm characteristics, procedural parameters, complications, and degree of initial and short-term aneurysm occlusion were evaluated on an intention-to-treat basis. Results A total of 16 unruptured aneurysms in 9 patients were treated with the Derivo® 2heal® Embolization Device in 10 treatment sessions. In one case the Derivo® 2heal® Embolization Device could not be deployed due to severe friction in the microcatheter. In all successful cases, one Derivo® 2heal® Embolization Device was sufficient to treat the target aneurysm and no additional coiling was performed. In-stent balloon angioplasty was performed in one procedure (10%) to improve vessel wall apposition. Twelve arterial side branches were covered in 9 procedures and all were patent at the end of the procedure. There were no clinical complications and no thromboembolic events during treatment. At the end of the procedure, contrast retention was observed in 13/16 (81%) aneurysms and at short-term follow-up, 6/9 (67%) were completely occluded. Conclusions The preliminary results of the new Derivo® 2heal® Embolization Device appear promising and warrant further evaluation by multicentre studies with long-term follow-up.