Cerus Endovascular has received CE mark approval for its lead product, the Contour Neurovascular System, for the treatment of intracranial aneurysms. The system incorporates a fine mesh braid that is deployed across the neck of the aneurysm sac and provides a combination of flow diversion and flow disruption through a single device implant. According to the company’s press release, commercial sales, via a controlled market release across the European Union (EU), are expected to begin during the second quarter of 2020.
CE mark approval was based on data generated from the company’s two EU studies evaluating the safety and efficacy of the Contour Neurovascular System, focusing on unruptured intracranial aneurysms. The latest, completed in 2019, was conducted at six sites in Germany, Austria and Denmark, while the earlier study included four sites in the United Kingdom and Hungary. 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.
“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,” stated Stephen Griffin, president of Cerus Endovascular.
He added: “Importantly, physicians who have used the system have highlighted the benefits inherent in its simplicity, including a simple sizing approach of the device to the aneurysm width, ease of deliverability and controlled deployment.”
“CE mark approval 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,” stated Sam Milstein, chairman of Cerus Endovascular.