New Device for Intracranial Aneurysm Approved in Europe

February 18, 2020

Cerus Endovascular has announced that it has received European CE Mark approval for its lead product, the Contour Neurovascular System, for the treatment of intracranial aneurysms.

The device is a fine mesh braid that is deployed across the neck of the aneurysm sac away from the vulnerable dome and provides a combination of flow diversion and flow disruption. It is designed to be self-anchored for stability, re-sheathable for precise placement, and because it is deployed across the neck, sizing criteria are less restrictive than other commercially available intrasaccular devices, making it easier to use in the clinical setting, Cerus states.

A controlled market release across the European Union is planned to begin in the second quarter of 2020.

The approval was based on data from two European studies evaluating the safety and efficacy of the device focusing on unruptured intracranial aneurysms. Data from the first study has been presented at a number of scientific conferences in early 2020, while data from the second, most recent study will be presented later this year, the company says.

Stephen Griffin, PhD, president of Cerus Endovascular, said the results show that the Contour Neurovascular System "represents a new, and potentially disruptive, standalone solution for the treatment of bifurcated saccular intracranial aneurysms compared to currently available technologies."  Benefits are said to include "a simple sizing approach of the device to the aneurysm width, ease of deliverability, and controlled deployment."

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