UK: A new device for the treatment of intracranial aneurysms -- Contour Neurovascular System -- has received European CE Mark approval, announced medical device company Cerus Endovascular.
The device is a unique, 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. 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," Dr. Stephen Griffin, President of Cerus Endovascular, said in a press release. "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."
"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," stated Dr. Sam Milstein, Chairman of Cerus Endovascular. "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."
About the Contour Neurovascular System
The Contour Neurovascular System, composed of fine mesh braid, represents a unique intrasaccular advancement in the market, as it targets the neck of the aneurysm, away from the vulnerable dome. Additionally, the System is designed to be self-anchored for stability, re-sheathable for precise placement, and because it is deployed across the neck, sizing criteria are less restrictive than other commercially available intrasaccular devices, making it easier to use in the clinical setting.
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