First Patients Enrolled in Study of Cerus' Contour System to Treat Intracranial Aneurysms
November 13, 2018—Cerus Endovascular Ltd. announced enrollment of the first patients in the CERUS study. The European premarket study is designed to assess the safety of the company's Contour neurovascular system for the treatment of unruptured intracranial aneurysm to reduce the risk of rupture.
The Contour neurovascular system, which is for investigational use only, is a next-generation intrasaccular flow diverter and flow disruptor that targets the neck of an aneurysm.
CERUS is a prospective, 30-patient, single-arm, multicenter trial that is being conducted at 10 leading European neurologic centers in Germany, France, Austria, and Denmark. Enrollment is expected to be complete within the next 4 months.
The study's coprincipal investigator, Professor Thomas Liebig, MD, of Ludwig Maximillians University Hospital in Munich, Germany, performed three of the first four cases in the study.
In the company's announcement, Prof. Liebig commented, "The Contour system combines the benefits of flow disruption and redefinition of the aneurysm-to-parent-vessel border without any material in the parent artery. Thus, it doesn't mandate long-term antiplatelet therapy." Prof. Liebig continued, "Sizing was straightforward in these first cases and was done with regard to the neck only since the Contour does not aim for bulk replacement of the aneurysmal cavity. Angulation and irregularity of the aneurysm dome seemed to play a lesser role, as well. We are aware of the need for a more valid database with more cases to support these impressions but at the moment we are quite content with our initial experience and look forward to the coinvestigators experiences and to the first control visit of the patients we have treated so far."