Cerus Endovascular's Contour Neurovascular System Approved in Europe
July 6, 2017—Cerus Endovascular Ltd announced that it has received CE Mark approval for the commercial sale of its Contour neurovascular system for treating intracranial aneurysms across the European Union. The company intends to initiate a controlled commercial rollout in select countries that recognize the CE Mark through a direct sales force during the third quarter of 2017. Additionally, the company advised that it is advancing discussions with regulators in the United States and other key markets.
According to the company, the Contour neurovascular system for the treatment of unruptured intracranial brain aneurysms targets the neck of the aneurysm away from the vulnerable dome. The device is a preshaped structure of fine mesh braid with shape memory properties that is delivered to the aneurysm via an endovascular microcatheter. The Contour system is deployed at the neck of the aneurysm sac and provides a combination of flow diversion and flow disruption through a single device implant. The self-anchoring, resheathable device provides stability and precise placement. Because it is deployed across the neck, sizing criteria are less stringent, making it easier to use.
Cerus Endovascular is currently conducting a 45-patient, single-arm, multicenter pilot trial designed to demonstrate the safety of the Contour neurovascular system in treating unruptured aneurysms. The study is being conducted at four leading neurological centers in the United Kingdom and one in Hungary. With CE Mark approval, the company plans to conduct future prospective clinical trials through the initiation of a postapproval study and registry.
In Cerus Endovascular's announcement, Tufail Patankar, MD, commented, "The evolution of aneurysm treatment, from surgery, to endovascular coils, to mesh baskets, has created new modalities that are less invasive and increasingly effective. 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 maneuvers are required within and around the aneurysm than with other available device classes, such as flow diverters, allowing for safer embolization, reduced rupture rates, shortened procedure times, and superior patient outcomes." Dr. Patankar is a consultant interventional neuroradiologist at Leeds General Infirmary in Leeds, United Kingdom.