Cerus Endovascular has received CE Mark approval for the commercial sale of its Contour Neurovascular System to treat intracranial aneurysms (IAs) across the European Union (EU).
The system is a pre-shaped structure of fine mesh braid with shape memory properties that is delivered to an aneurysm via an endovascular microcatheter and is currently approved for sale across the EU.
It is deployed at the neck of the aneurysm sac and provides a combination of flow diversion and flow disruption through a single device implant.
Through a direct sales force, the company plans to start a controlled commercial rollout in select CE Mark countries during the third quarter of this year.
Cerus Endovascular founder, chairman and chief executive officer Todd Derbin said: "CE Mark approval of our Contour Neurovascular System represents a significant milestone not only for our company but, more importantly, for the millions of patients worldwide who carry the risks posed by unruptured intracranial brain aneurysms.
"We have designed the Contour Neurovascular System to deliver significant clinical advantages versus competing technologies.
"Notably, the system targets the neck of the aneurysm away from the vulnerable dome, it is self-anchoring for stability, it is re-sheathable for precise placement, and since it is deployed across the neck, sizing criteria are less stringent, making it easier to use.
"Further, based on patients treated to date in a compassionate use setting, Contour achieved a 100% implant success rate with an excellent safety profile."
Currently, the company is conducting a 45-patient single arm, multi-center pilot trial at four leading neurological centres in the UK, and one in Hungary.
The trial is designed to demonstrate the safety of the Contour Neurovascular System to treat unruptured aneurysms.
With CE Mark approval, the company intends to conduct future prospective clinical trials through the initiation of a Post Approval Study and Registry.