Cerus Endovascular announced today that it won CE Mark approval for its Contour neurovascular system for treating intracranial aneurysms.
The Contour system is a mesh braid designed to be deployed across the neck of an aneurysm sac, providing flow diversion and flow disruption in combination through a single device implant.
Contour is also designed to be self-anchored for stability and re-sheathable for precise placement. Cerus touts the system as less restrictive than other commercially available intrasaccular devices, thanks to its sizing criteria that makes it easier to use in a clinical setting.
Cerus conducted two studies in Europe to evaluate the safety and efficacy of the Contour, with the most recent one completed last year. The company conducted the trial across six sites in Germany, Austria and Denmark, while the previous study covered four sites in the United Kingdom and Hungary.
Cerus Endovascular president Stephen Griffin said in a news release that the growing clinical data to back up the Contour system represents a “potentially disruptive” solution for treating intracranial aneurysms, especially compared to the currently available technology.
“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,” Griffin added.
The company said it intends to begin commercial sales through a controlled market release across the European Union during the second quarter of 2020.
“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 chairman Sam Milstein said in the news release.