US-based medical device company Cerus Endovascular has secured CE Mark approval for Contour Neurovascular System, intended to treat intracranial aneurysms.
A mesh braid across the neck of the aneurysm sac, the Contour Neurovascular System offers a combination of flow diversion and flow disruption through one device implant.
Furthermore, designed to be self-anchored for stability, the system can target the neck of the aneurysm, away from the vulnerable dome.
The company expects to begin commercial sales, through a controlled market release across the European Union (EU), during the second quarter of 2020.
The firm secured the CE Mark approval based on data generated from its two EU studies analysing the safety and efficacy of the System, focusing on unruptured intracranial aneurysms.
The latest study completed last year took place at six sites in Germany, Austria and Denmark.
The earlier study took place in four sites in the UK and Hungary.
Data from the first study was presented at several scientific conferences early this year, while data from the second study will be presented later this year.
Cerus Endovascular president Dr Stephen Griffin said: “As our clinical data experience grows, and more physicians use the System, results continue to be compelling – providing additional confirmation that the Contour Neurovascular System delivers an important clinical option and represents a new, and potentially disruptive, standalone solution for the treatment of bifurcated saccular intracranial aneurysms compared to currently available technologies.
“Importantly, physicians who have used the System have highlighted the benefits inherent in its unique simplicity, including a simple sizing approach of the device to the aneurysm width, ease of deliverability and controlled deployment.”