Updated to correct that the company is Cerus Endovascular, with no relation to Cerus Corp.
Cerus Endovascular said today it won CE Mark approval in the European Union for its Contour neurovascular system designed for treating intra-cranial aneurysms.
The Fremont, Calif.-based company said the Contour system is designed with a fine mesh braid deployed at the neck of an aneurysm sac to provide both flow diversion and flow disruption. Cerus said it intends to initiate a controlled rollout of the device in select markets in the EU during the 3rd quarter of this year.
“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. Tufail Patankar of the UK’s Leeds General Infirmary said in a prepared statement.
Cerus said it is conducting a 45-patient pilot trial examining the safety of the Contour system in treating unruptured aneurysm, and expects to conduct future prospective clinical trials through the initiation of a post approval study and registry.
“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. 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,” CEO J. Derbin said in a press release.