The CE Mark approval was based on data from two European clinical studies evaluating safety and efficacy of Contour Neurovascular System
US-based medical device firm Cerus Endovascular has obtained CE Mark approval for its Contour Neurovascular System, designed to treat intracranial aneurysms.
The company said that its Contour Neurovascular System is an advanced fine mesh braid intended to be deployed across the neck of the aneurysm sac. The system offers a combination of flow diversion and flow disruption through a single device implant.
In addition, the design of the system enables it to be self-anchored for stability, re-sheathable for precise placement, and offers less restrictive sizing criteria, compared to other available intrasaccular devices.
Cerus Endovascular chairman Sam Milstein said: “Congratulations go out to the entire company, including our new management team, who were instrumental in pushing these studies forward, leading to our first regulatory approval and the achievement of a number of other, as yet unannounced, key milestones.
“CE Mark approval, a critical step in our go-to-market strategy, has propelled us from the research and development stage to a commercial stage company, and we are eager to begin this next phase by making the Contour Neurovascular System available to physicians and patients across the EU in a controlled roll-out.”
Cerus intends to commercialise the product during the second quarter of 2020
Cerus said that the CE Mark approval was supported by the data generated from two European clinical studies that evaluated the safety and efficacy of its Contour Neurovascular System, for unruptured intracranial aneurysms.
The latest of the studies, carried out at six sites in Germany, Austria and Denmark, was completed in 2019, while the earlier study was conducted at four sites in the UK and Hungary.
The company is planning to start the commercial sales of the product across the European Union (EU), through a controlled market release, during the second quarter of 2020.
Cerus Endovascular president Stephen Griffin said: “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.”