The Contour Neurovascular System (Cerus Endovascular) has received CE mark approval for the treatment of intracranial aneurysms. Contour is a unique, fine mesh braid that is deployed at the neck of the aneurysm sac and provides a combination of flow diversion and flow disruption through a single device implant.
According to a release, the company intends to initiate a controlled commercial rollout in select CE marking countries through a direct sales force during the third quarter of 2017.
“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 intra-cranial brain aneurysms,” says J Todd Derbin, founder, chairman and chief executive officer of Cerus Endovascular.
“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. Given these demonstrated attributes, we believe that Contour represents a true paradigm shift in the treatment of intra-cranial aneurysms, and we look forward to making this disruptive technology available to physicians in CE marking countries while advancing discussions with regulators in the United States and other key geographies,” Derbin adds.
“The evolution of aneurysm treatment, from surgery, to endovascular coils, to mesh baskets, has created new modalities that are less invasive and increasingly effective,” says Tufail Patankar, consultant interventional neuroradiologist at Leeds General Infirmary in Leeds, UK. “However, even current treatments can be complex and risky. In contrast, the unique design of Contour allows for treatment of the aneurysm with a single, versatile device that can be deployed with existing microcatheter techniques. As a result, fewer manoeuvres are required within and around the aneurysm than with other available device classes, such as flow diverters, allowing for safer embolisation, reduced rupture rates, shortened procedure times and superior patient outcomes.”
Cerus Endovascular is currently conducting a 45-patient single arm, multicentre pilot trial designed to demonstrate the safety of the Contour Neurovascular System in the treatment of unruptured aneurysms. The study is being conducted at four neurological centres in the UK and one in Hungary. With CE mark approval, the company plans to conduct future prospective clinical trials through the initiation of a Post Approval Study and Registry.