Cerus wins CE Mark for Contour neurovascular aneurysm system

Cerus (NSDQ:CERS) 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 Mar...
Source: Mass Device - Category: Medical Devices Authors: Tags: Regulatory/Compliance Vascular Cerus Corp. Source Type: news